RULES AND REGULATIONS
Title 28--HEALTH
AND SAFETY
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 25]
Hearing Aid Sales and Registration
[34 Pa.B. 2808] The Department of Health (Department) amends Chapter 25 (relating to controlled substances, drugs, devices and cosmetics) to read as set forth in Annex A.
A. Purpose and Background
The Hearing Aid Sales Registration Law (act) (35 P. S. §§ 6700-101--6700-802) governs the sale of hearing aids and regulates the related activities of hearing aid dealers and fitters. It imposes duties upon, and prohibits certain acts by, hearing aid dealers and fitters, and provides for penalties that may include denial, suspension or revocation of a dealer's or fitter's registration. The act was amended by the act of December 21, 1998 (P. L. 1190, No. 153) (Act 153). The changes made by Act 153 included imposing continuing education requirements upon hearing aid fitters and making failure to comply with those requirements a cause for denial, suspension or revocation of a registration certificate. Act 153 also raised the fees for registration certificates and required disclosure agreements and money-back-guarantees to be provided to purchasers and prospective purchasers of hearing aids. Act 153 required the Department to promulgate regulations to effectuate the continuing education requirements imposed by it.
Prior to Act 153, certain portions of the act were preempted due to regulations promulgated by the Federal Food and Drug Administration (FDA) under the Federal Food Drug, and Cosmetic Act (21 U.S.C.A. §§ 301--397, specifically 21 U.S.C.A. § 360k). The Federal regulations regarding hearing aids were published at 21 CFR 801.420 and 801.421 (relating to hearing aid devices; professional and patient labeling; and hearing aid devices; conditions for sale). A few Pennsylvania requirements that conflicted with the Federal regulations were conditionally exempted from preemption under the final rule issued by the FDA in Docket No. 77N-0333, dated October 10, 1980 (45 FR 67321) (Final Rule). This final-form rulemaking is responsive to the preemption issues raised by the Federal regulations and is intended to clarify the state of the law.
B. Summary
This final-form rulemaking breaks Chapter 25 into Subchapters A and B (relating to controlled substances, drugs, devices and cosmetics; and hearing aid sales and registration) to differentiate the regulations adopted under the act and pertaining to hearing aid sales and registration from the rest of Chapter 25, which otherwise consists entirely of regulations adopted under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101--780-144).
The Department received four comments on the proposed rulemaking. The commentators included the Independent Regulatory Review Commission (IRRC); James P. Rametta, Rametta Audiology and Hearing Aid Center; Dorothy Kardos, Central Pennsylvania Eye and Ear; and Dorothy Kardos, President, Pennsylvania Hearing Aid Alliance (PHAA), on behalf of PHAA. The comments and the Department's responses follow.
C. Comments
§ 25.201 (relating to application)
This section explains to whom the final-form rulemaking applies. No comments were received regarding this section. This section is adopted as proposed.
§ 25.202 (relating to definitions)
This section defines terms used in Subchapter B. IRRC commented that the terms ''hearing aid user,'' ''prospective hearing aid user'' and ''purchaser'' should also be defined to avoid confusion. The Department accepts this recommendation and has added definitions of these terms.
IRRC also questioned whether Commonwealth residents would be permitted to seek medical treatment for hearing problems from out-of-State physicians given that the definition of ''physician'' included in the proposed rulemaking is an individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth. Commonwealth residents may seek medical treatment from whomever they wish. However, the act requires an examination and recommendation from a physician, unless waived by the prospective purchaser. Since section 403 of the act (35 P. S. § 6700-203) permits a registrant to accept a medical recommendation from any licensed physician, the Department has deleted the proposed definition in response to the IRRC comment.
§ 25.203 (relating to Advisory Council)
This section establishes the Hearing Aid Advisory Council and requires annual meetings. The final-form rulemaking deletes the specific requirements as to the frequency and time of notice of meetings. This section did not engender comment. It is adopted as proposed.
§ 25.204 (relating to application for and renewal of registration)
This section establishes how registration certificates may be applied for and renewed. The proposed amendments to subsection (d) required registrants to apply to renew a registration certificate at least 30 days before it expired. IRRC suggested that, since all registration certificates expire on April 15, subsection (d) should state specifically that renewals must be submitted by March 16. The Department accepts this comment and has changed subsection (d) to include the date by which registrants must apply for renewal.
The Department clarified proposed amendments to subsection (e), which would provide that an expired registration certificate may be renewed within 5 years of its expiration by applying for renewal, paying the renewal fee and any delinquency fee due, and satisfying the applicable continuing education requirements. The Department has clarified that this also applies to registration certificates that their holders request be placed on inactive status. When a registration is placed on inactive status, it may be renewed for up to 5 years from the date it was made inactive. Although the statute does not specifically mention inactive certificates, the 5-year limit on renewal ensures that an individual who is ''out of practice'' cannot simply resume practicing after more than 5 years have passed without demonstrating competency to do so. The 5-year time limit therefore logically applies to individuals who have in effect directly informed the Department that they will not be practicing.
Proposed amendments to subsection (f) permitted an applicant to petition for more than two renewals of a temporary registration certificate, for good and sufficient cause. IRRC commented that subsection (f) should set forth the process for applicants to be able to do this. The Department accepts this comment and has included language that requires applicants to send a letter stating their reasons for requesting an additional renewal to the Division of Home Health's (Division) address. The Department will then determine whether or not the cause is sufficient so as to merit the additional renewal.
Proposed subsection (g), intended to inform registrants that a renewal not requested 30 days prior to the expiration of a registration certificate may not be received on time, did not specifically state the expiration date for registration certificates. IRRC suggested that the specific date of April 15 be used. The Department accepts this comment and has changed subsection (g) to state that a registrant who files for renewal after March 16 may not receive a renewal before the certificate expires.
§ 25.205 (relating to additional registration requirements)
This section establishes additional requirements to receive temporary and regular registration certificates. IRRC pointed out that proposed amendments to subsection (d)(3), which list the requirements for an apprentice hearing aid fitter to change sponsors, use the word ''affirmed'' to apply to statements which must be filed by the apprentice giving reasons for the desired change, and by the prospective sponsor. IRRC suggested that the Department should explain how affirmation is accomplished. The Department accepts this comment, and has changed § 25.205(d)(3) to make clear that affirmation may be given in any form so long as it is in writing, signed and contains a statement to the effect that it is truthful.
IRRC also asked whether subsection (d)(3) and (4), having to do with how an apprentice may change sponsors or how a sponsor may terminate responsibilities with regard to an apprentice, requires good cause to be shown. The Department will not require good cause. An explanation is required when an apprentice wishes to change sponsors, largely to enable the Department to ensure that a sponsor is not repeatedly failing in his duties when the sponsor agrees to take on an apprentice. However, a simple representation that the relationship is not working out to the satisfaction of one or both parties will suffice. The Department has made no changes to subsection (b) in response to the comment.
§ 25.206 (relating to examinations)
This section establishes a schedule for the fitter examinations. IRRC commented that the Department should provide the actual address to which a prospective exam taker should write to obtain the date of the next examination, and should also clarify whether it would be possible to request an examination date by e-mail or telephone. The Department accepts these comments, and has modified subsection (b) to refer to the address in § 25.204(a). Subsection (b) has also been changed to state that individuals may telephone or e-mail the Division, and also provides the Department's website, on which the Department intends to post the examination dates and contact information.
§ 25.207 (relating to categories of registrations; fee schedule)
This section establishes registration fees and requirements for registration certificates. IRRC commented that the Department could reword the proposed amendments to subsection (h) to make it more understandable. The Department accepts this comment, and has reworded subsection (h) as suggested.
§ 25.208 (relating to display of registration certificates; offices)
This section sets out requirements for the information contained on registration certificates. IRRC asked that the Department explain the process for filing a notice of a change in the registrant's place of business, as required in the proposed amendments to subsection (d). The Department has modified subsection (d) to state that registrants should file notice of a change in their business addresses by writing to the Department at the address given in § 25.204(a).
§ 25.209 (relating to facilities, procedures and instrumentation)
This section includes requirements for physical facilities, testing and fitting procedures and standards for instruments. IRRC pointed out that the Department proposed to delete from subsection (b)(1) a list of persons who the fitter should verify performed the test and to substitute the phrase ''individual authorized by law.'' IRRC suggested that the Department should restore the phrase to facilitate understanding of who the Department considers to be individuals who are authorized by law. However, the Department feels that without the change, subsection (b) could lead a registrant to believe that anyone supervised by a physician, audiologist or fitter is authorized by law to perform hearing tests, which is not necessarily the case. To clarify the proposed changes to subsection (b) and to respond to concerns, the Department has revised subsection (b)(1) to state that a registrant may rely on a representation made by an appropriately licensed individual under whose auspices the testing is being done, that the testing was performed by an appropriately authorized individual.
IRRC pointed out that subsection (c)(1), requiring test instruments to be calibrated in accordance with current standards set by the American National Standards Institute (ANSI), refers to standards that were published in 1969. The most recent ANSI standards in this area were published in 1996. The Department has revised subsection (c) to reference the 1996 ANSI standards.
§ 25.210 (relating to receipt, disclosure agreement and money back guarantee to purchaser--purchaser protection)
This section lists requirements for receipts, establishes a form disclosure agreement/money back guarantee and provides instructions for its use. All of the commentators indicated that initial screening and testing would be necessary to determine whether a patient needs a hearing aid. However, proposed subsection (b), which included the disclosure agreement requirements, required completion of the entire disclosure agreement and money back guarantee form to be completed prior to the provision of any services. Given the variety of hearing aids available, costs cannot be accurately estimated prior to completing an examination. The commentators indicated that the form should be restructured to accommodate the order in which the activities of testing, fitting and selecting a hearing aid are done. IRRC specifically stated that the final-form rulemaking should require that Part A of the form be completed with the patient's signature, date and time prior to testing. Once the testing has been finished, Part B should be completed.
The act, however, requires registrants to provide a disclosure agreement that is to be explained in detail and signed by the registrant and the consumer prior to the provision of any service. The disclosure agreement must contain a complete description of what the fitting procedure does and does not include, and an itemization and disclosure of all fees associated with the fitting procedure or process and the sale and delivery of a hearing aid or similar device, including any cancellation fees authorized by the act.
In deference to these comments, particularly from the practitioners who indicate that it is necessary for them to be able to do the disclosure agreement in stages, the Department has revised the disclosure agreement/money back guarantee form and proposed subsections (b) and (c) to accommodate both the statutory requirements and the needs of the commentators. Subsection (b) has been revised to clarify that the disclosure agreement/money back guarantee must be provided and explained in detail in accordance with subsection (c) before the provision of any service.
The revisions to subsection (c)(1) require registrants to complete and explain Part A of the disclosure agreement/money back guarantee in detail, in deference to the statutory requirement that a complete description of what the fitting procedure or process includes must be given and fees associated with the fitting procedure or process and the sale and delivery of the hearing aid must be itemized and disclosed. This is intended to ensure that purchasers understand what services they are paying for and requires registrants to break out each service separately. Registrants should be especially certain to separate those services which are rendered in connection with the fitting process from those which are connected with the sale and delivery of a hearing aid and which might occur after a hearing aid is actually delivered. This statutory requirement is particularly important to understand in light of the fact that if a purchaser cancels an order for a hearing aid prior to delivery, any moneys paid for services not yet rendered must be refunded. These services must, therefore, be itemized separately.
Registrants would also be required to preliminarily explain Part B, including any cancellation fees that might be incurred if an individual purchases and then returns a hearing aid. Subsection (c)(1) states that, if registrants do not charge fees for services, they should note that in Part A of the disclosure agreement.
Revised subsection (c)(2) requires the registrant to sign and have the prospective user or authorized representative sign the disclosure agreement after Part A has been explained and completed and Part B has been preliminarily explained. The disclosure form itself has changed to permit both the registrant and the customer to sign the disclosure agreement/money back guarantee under Part A at this juncture. The statement below Part A, which has been added to as proposed, states that the disclosure agreement was provided, Parts A and B were explained, Part A was completed before any services were provided and that Part B was completed after services were provided and before any payment was made. The disclosure agreement thus contemplates the possibility that the registrant or prospective hearing aid user may elect not to proceed after testing by stating that ''If Part B is not completed, it is because a hearing aid was not recommended or not desired.'' This allows for the fact that the prospective user may not need a hearing aid, the registrant may not wish to recommend one or the prospective user may not wish to purchase one at the time the testing is done. These possibilities are reflected in subsection (c)(3), which instructs the registrant how to proceed if Part B becomes inapplicable. If Part B is completed, it must also be fully explained at that time, before any payment is provided.
A statement has been added after Part A to clarify that refunds of fees which are ordered by a court under the Commonwealth's consumer protection laws will not be affected by the characterization in the disclosure agreement of these fees as ''not refundable.'' The Attorney General, who enforces the Commonwealth's consumer protection laws, was concerned that the disclosure agreement would mislead consumers and registrants to believe that refunds could not be ordered by a court of competent jurisdiction. Clarifying language suggested by the Attorney General was added to the disclosure agreement.
The next step in the process is for the registrant to explain the money-back guarantee. If the prospective user or authorized representative decides to purchase a hearing aid, the purchaser and registrant sign the signature lines under the guarantee and the purchaser should complete the time and date line. See subsection (c)(4). Proposed subsection (c)(4)--(6) has been deleted and replaced in accordance with the revisions to the disclosure agreement. The information in those paragraphs that is relevant to the revised form has been included elsewhere in subsection (c).
Subsection (c)(5) makes clear that a registrant may still extend the money back guarantee beyond 30 days if the registrant wishes to do so and that the 30 day period starts on the date of delivery of the hearing aid. Subsection (c)(6) explicitly instructs the registrant to provide the customer with a copy of the disclosure agreement after it is fully completed except for the serial number of the hearing aid and the block that is concerned with the date and time of delivery.
IRRC also questioned why it is necessary to have the time and date recorded twice on the form if the entire form must be completed prior to rendering any services. It is important to recognize the separation between the services that are rendered in connection with the fitting of the hearing aid, the sale of the hearing aid and the delivery of the hearing aid to the purchaser. The form as proposed did allow for the prospective user to sign before any fitting services were provided, and then sign again when the decision to purchase was made. It is important that the registrant provide the required information and services before the prospective user agrees to the sale. Recording the time that each signature is made is intended to provide some evidence that the time between the initial explanation of the form and the decision of the prospective user or authorized representative to purchase the hearing aid has allowed for the provision of services. If the serial number is not known until the hearing aid is delivered, this information may be filled in or updated at that time. Now that the Department has clarified the fact that the first signatures are to be completed before any services are provided and the second signatures are to be contemporaneous with the sale, the time of each signature remains an important piece of evidence that registrants have properly followed the process as outlined in subsection (c). In addition, the requirement to record the date of delivery on the form provides evidence of the start of the 30-day money back guarantee period.
IRRC further suggested that the Department allow for registrants to use forms other than those provided by the Department. The Department accepts this comment, and has revised subsection (b) to include the words ''or on a form approved by the Department.''
Two commentators pointed out that ear molds are not part of the hearing aid, and should not be included in the price of the hearing aid for refund purposes. Because the ear molds are not returnable to a manufacturer (as hearing aids are), registrants should be able to retain the entire cost of the ear mold even if the hearing aid is returned. However, as one of the commentators indicated, the act mandates that a purchaser is entitled to a refund of the price of the hearing aid and accessories together, except for a cancellation fee of the lesser of $150 or 10% of the price of the hearing aid and accessories. Ear molds are included in ''accessories.'' The Department, therefore, has made no changes to the final-form rulemaking in response to these comments.
Commentators also referenced a statement in the preamble to the proposed rulemaking which stated that registrants do not suffer a great financial loss when a purchaser returns a hearing aid, since manufacturers give credit for returns. The commentators pointed out that return of a hearing aid has an ultimate financial impact on registrants and end users alike. Under FDA regulations, manufacturers cannot resell a returned hearing aid as new or use any part of it in a hearing aid that is to be designated as new. Any losses suffered by manufacturers as a result of a return are recovered in the prices of new hearing aids. More returns must necessarily result in higher prices for hearing aids. The commentators did not suggest changes to the rulemaking in connection with this point. As the act establishes the return policy and FDA regulations govern when a hearing aid may be considered new, the Department made no changes to the regulations in response to these comments.
§ 25.211 (relating to medical recommendations; waiver forms)
This section requires registrants to obtain medical recommendations or waiver forms signed by the prospective user before selling a hearing aid. IRRC pointed out that proposed amendments to subsection (a) incorrectly allow an individual who is ''18 years of age'' to sign a waiver form. In fact, the act requires a medical examination for individuals 18 years of age or younger who are buying a new hearing aid. The language has been corrected to read ''19 years of age or older.''
IRRC stated that the phrase ''a legally proper waiver'' as used in proposed subsection (b) is unclear, and questioned whether both the State and Federal medical waiver forms are legally proper. Both the State and Federal waiver forms are legally proper where the sale of a used hearing aid is concerned. Subsection (b) has been revised to explicitly state that a legally proper waiver in this limited circumstance is either the State or Federal waiver form.
§ 25.212 (relating to medical recommendations by examining physicians)
This section as proposed sets out the requirements for medical recommendations provided by physicians. No comments were received regarding this section. This section is adopted as proposed.
§ 25.213 (relating to consumer review)
This section establishes additional documentation that must be provided to a prospective hearing aid user, and incorporates certain requirements of the Unfair Trade Practices and Consumer Protection Law (UTPCPL) (73 P. S. §§ 201-1--209-6). IRRC expressed concern with subsection (b), which permits consumers to avoid contracts for sale entered into in connection with a contact with or call on a purchaser at the purchaser's home. The proposed amendments to subsection (b) state that a notice of rescission is effective ''when deposited'' in the United States mail. IRRC asked when the notice is considered to be ''deposited.'' This common legal presumption does allow for a rescission to be effective when it is deposited in the mail, even though the registrant will not be aware of the rescission until it is delivered. In this way, the consumer has the full 3 days to change his mind; if the consumer had to ensure that the rescission was delivered within the 3 days, there would effectively be no ''cooling off'' period. The issue pointed out by IRRC is a possible evidentiary problem, which could arise in the context of a dispute as to when the notice was deposited, particularly in the absence of a postmark or other written evidence as to when the notice was deposited (such as a receipt for certified mail). The evidentiary question at that point would rest with the factfinder in the dispute.
IRRC was also concerned that subsection (b) is not clear enough as to the other permissible ways that the registrant may be given notice of rescission, and recommended that the Department list those ways. The Department will not implement this recommendation. These requirements are found in the UTPCPL. They are applicable whether or not incorporated in the Department's regulations; they are so incorporated because the act permits the Secretary to deny, suspend or revoke a registrant's certificate for untruthfulness or bad reputation in general, and more specifically for being enjoined from a violation of the UTPCPL. Incorporation in this manner places a registrant on more specific notice of the UTPCPL requirements. However, the Attorney General has primary responsibility for enforcement of the UTPCPL. The Department believes that specifically listing methods of service by which registrants are placed on notice of rescission could prove to be misleading to registrants, since the Attorney General's Office may ultimately interpret what is permitted under the UTPCPL differently than the Department. The Department has combined subsections (b) and (c) to clarify that all the requirements discussed are drawn directly from the UTPCPL and that the statute is controlling in this matter.
§ 25.214 (relating to recordkeeping)
This section contains recordkeeping requirements for registrants. No comments were received regarding this section. This section is adopted as proposed.
§ 25.215 (relating to denial, revocation or suspension of a registrant's certificate)
This section as proposed listed reasons for which a registration certificate may be denied, revoked or suspended. No comments were received regarding this section. The reference to the ''United States Department of Health, Education and Welfare'' was corrected to say ''United States Department of Health and Human Services.'' This section is otherwise adopted as proposed.
§ 25.216 (relating to continuing education requirements)
This section as proposed established continuing education requirements and stated how they relate to the renewal of a registration certificate. The Department has changed the phrase ''would need to,'' found in subsection (b), to ''shall.'' This enhances the clarity and grammatical correctness of the provision, but does not change the requirement therein. IRRC properly pointed out that the date on which the first 2-year period for which continuing education requirements are applicable did not begin on April 15, 2002, as stated in the preamble in the Department's submission to IRRC, but on April 15, 2003. This correction was made by the Legislative Reference Bureau prior to publication of the proposed rulemaking.
§ 25.217 (relating to approval of continuing education programs)
This section as proposed established requirements for continuing education programs. IRRC commented that the content of proposed subsection (a)(1) is adequately covered in proposed subsection (a)(2). The Department has deleted proposed subsection (a)(1). IRRC questioned how the Department will enforce the requirement in proposed subsection (a)(4) (adopted as subsection (a)(3)) that materials will be ''well written.'' The Department has responded to this comment by requiring that written materials used in continuing education programs must be ''clear, informative and grammatical,'' which the Department believes may be ascertained by reading the materials.
IRRC also asked what it meant to be a ''qualified'' instructor, as stated in proposed subsection (a)(5) (adopted as subsection (a)(4)). The Department does not wish to implement rigid standards having to do with credentials or being approved by certain National organizations that fulfill these functions. Some fitters who have submitted and led their own continuing education programs have done an excellent job, and the Department would like these individuals to continue to contribute to the continuing education process. To be responsive to IRRC's concerns, the Department has deleted the word ''qualified'' and substituted the phrase ''experienced and knowledgeable in the subject matter taught.'' Whether an instructor is experienced and knowledgeable will be evaluated on a number of factors including qualifications, experience, the quality of the materials submitted in support of the program and any other relevant information that can be obtained, including any feedback offered by registrants who are familiar with the instructor or the program.
Finally, IRRC questioned what is meant by a ''suitable setting,'' as that phrase is used in proposed subsection (a)(5) (adopted as subsection (a)(4)). The Department does not intend, nor have the resources, to investigate all of the physical areas in which programs may be offered. However, it is anticipated that complaints may be received if the setting in which a continuing education course was offered was particularly inappropriate in some aspect. If complaints prove to be valid, including this requirement will enable the Department to ensure that a provider does not continue to provide a course in an inappropriate setting. The Department has therefore reworded this subsection to require ''a setting conducive to learning the material being taught, including any necessary equipment or facilities.''
A commentator suggested that no more than 1/3 of all continuing education credits should be able to be obtained from any one manufacturer, and stated that certain manufacturers exclude persons from educational programs they offer. The commentator further stated that no continuing education credits should be accepted from any group that does not open their seminars to all fitters. In accordance with subsection (a)(5) (proposed as subsection (a)(6)), continuing education programs must be open to all persons with a current, suspended or expired registration certificate in order to be approved by the Department.
§ 25.218 (relating to credit for continuing education)
This section as proposed sets out the requirements for obtaining continuing education credits. Proposed subsection (e) (adopted as subsection (f)) required registrants to supply the Department with the materials the Department requests for evaluation prior to preapproving a self-study continuing education course. In its comments, IRRC asked what materials are to be provided. The Department has changed the subsection to clarify that the Department may require any of the materials to be used in the course to be provided for review. The Department also clarified, in response to IRRC's comments, that approval may be applied for after the course is taken, although the Department cannot guarantee that it will approve a course which has already been taken.
IRRC further commented that proposed subsections (c) and (g) deal with similar issues and should be combined. The Department respectfully disagrees. Proposed subsection (c) permitted a fitter to receive continuing education credits for serving as an instructor, with the caveat that only half of the required credit hours for a renewal may be fulfilled through instruction; the other half must be acquired by attending continuing education programs. Proposed subsection (g) stated that the same program may not be attended or taught for credit towards a single renewal of a fitter's registration certificate, but that the same program may be taught or attended again for a subsequent renewal. The Department considers these to be two different subjects, which should be placed in separate subsections. Because both of the provisions are related in that they do discuss teaching for continuing education credit, proposed subsection (g) was moved to become subsection (d) so that it could be read and compared more easily with subsection (c). It is intended that the subsections will be understood more clearly as a result. The remainder of the section has been renumbered accordingly.
The Department has changed proposed subsection (a) to state that no credit shall be ''given'' rather than ''received'' if the person offering the program determines that a fitter has not participated in a continuing education program adequately to earn the credit. This change contributes to grammatical correctness and clarity, but does not change the requirement stated in subsection (a).
It should be noted that section 311 of the act (35 P. S. § 6700-311) requires fitters to have completed, during the 2 years immediately preceding the expiration date of the certificate, 20 credits of continuing education. The practical effect of the requirement not permitting the same program to have been taught or attended twice for the renewal of a registration, means that during the 2-year ''look back'' period for that renewal, the same course cannot appear as having been taught or attended twice. The first full 2-year period begins April 15, 2003. On April 15, 2005 (the first renewal for which the full 20 credits will be required), a fitter cannot have taken or taught the same course twice for credit. If a fitter took one particular course May 1 of 2003, that course could be taken again for credit toward the April 15, 2006, renewal, because the 2-year look back period for the April 2006 renewal would run from April 15, 2004, to April 15, 2006, so the credits acquired May 1, 2003, would no longer be valid. If the fitter took the same course on May 1 of 2004, however, the course could not be taken again until after April 15, 2006, because the course would be included in the 2-year look back for the April 15, 2006 renewal.
§ 25.219 (relating to responsibilities of persons offering continuing education programs)
This section as proposed imposed certain requirements on providers of continuing education programs. No comments were received regarding this section. This section is adopted as proposed.
§ 25.220 (relating to right to enter, inspect and obtain records)
This section as proposed established under what circumstances a Department representative may inspect or obtain records from a registrant. No comments were received regarding this section. This section is adopted as proposed.
§ 25.221 (relating to exceptions)
This proposed section permitted the Department to grant exceptions to the regulations for good cause, except for statutory requirements repeated therein. No comments were received regarding this section. This section is adopted as proposed.
D. Fiscal Impact
The final-form rulemaking adopts the increased registration fees for hearing aid dealers and fitters imposed by Act 153. Additionally, hearing aid fitters will incur costs to obtain the continuing education credits required by Act 153. Because the fees set forth in the final-form rulemaking merely repeat the fees imposed by the act and the amount of continuing education required is also imposed by statute, almost all costs directly attributable to the regulations are costs that will be incurred by persons who need to meet regulatory requirements to offer continuing education courses. However, persons offering continuing education credits are permitted to charge persons who attend those courses, and may recoup their costs through enrollment fees. One cost that is directly attributable to the regulations will be the cost incurred by registrants due to having used the Department's disclosure agreement/money back guarantee form. Registrants may also incur some costs due to the establishment, in Act 153, of a 30-day money-back guarantee to purchasers, which may enable purchasers to return hearing aids where registrants otherwise might not have permitted them to do so. However, Act 153 does allow registrants to retain the lesser of $150 or 10% of the purchase price of each hearing aid with accessories, so it is unlikely that registrants will suffer actual financial loss due to the new requirement.
E. Paper Requirements
The final-form rulemaking will result in some additional paperwork for the Commonwealth in that the Department will be responsible for ensuring that hearing aid fitters have met their continuing education requirements. Hearing aid fitters will also need to retain records enabling them to establish that these requirements are met. Registrants will need to provide to each customer the disclosure agreement and money-back guarantee required by Act 153, and will also be required to retain copies of those documents in their records. Persons who offer continuing education courses will need to satisfy paperwork requirements.
The final-form rulemaking attempts to reduce necessary paperwork by enabling registrants to use alternative forms of payment to pay fees, including credit cards, and by including the Department's website, which will contain much of the information that registrants need to fulfill the regulatory requirements.
F. Effective Date/Sunset Date
The final-form rulemaking is effective upon publication in the Pennsylvania Bulletin. No sunset date is established. The Department will monitor the effectiveness of the regulations on a continuing basis and make changes as needed.
G. Statutory Authority
The Department's general authority to promulgate regulations is established by section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)). The Department is given specific authority to promulgate rules and regulations to enforce the act in section 205 of the act (35 P. S. § 6700-205), which section was amended by Act 153 to include the authority to promulgate regulations to effect the new requirements of Act 153.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on October 22, 2003, the Department submitted a copy of the notice of proposed rulemaking, published at 32 Pa.B. 3223 (July 6, 2002), to IRRC and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC and the House and Senate Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 11, 2003, the final-form rulemaking was deemed approved by the House and Senate Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on December 4, 2003, and approved the final-form rulemaking. The Office of Attorney General approved the regulations on May 12, 2004.
I. Contact Person
Questions regarding the final-form rulemaking should be submitted to Theresa A. Ritchie, R.Ph., Director, Hearing Aid Program, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 783-1379. Persons with disabilities who require an alternative format of these regulations (for example, large print, audiotape or Braille) should contact Theresa A. Ritchie so that necessary arrangements may be made, for speech or hearing, or both, impaired persons, V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Services at (800) 654-5984.
J. Findings
The Department finds:
(1) Public notice of the intention to adopt the amendment adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law.
(3) The adoption of the final-form rulemaking in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes.
K. Order
The Department, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 28 Pa. Code Chapter 25, are amended by amending §§ 25.201--25.215 and by adding §§ 25.216--25.221 to read as set forth in Annex A
(b) The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.
(c) The Secretary of Health shall submit this order, Annex A and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for review and action as required by law.
(d) The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect upon publication in the Pennsylvania Bulletin.
CALVIN B. JOHNSON, M.D., M.P.H.,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 34 Pa.B. 6376 (December 20, 2003).)
Fiscal Note: Fiscal Note 10-165 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter A. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS
Subchapter B. HEARING AID SALES AND REGISTRATION § 25.201. Application.
(a) Scope. This subchapter applies to all persons engaged in the business of selling or fitting hearing aids in this Commonwealth; except that physicians and audiologists are exempted from all provisions regarding hearing aid fitters.
(b) Authority. This subchapter is adopted under the act.
§ 25.202. Definitions.
The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
Act--The Hearing Aid Sales Registration Law (35 P. S. §§ 6700-101--6700-802).
Advertise and any of its variants--The use of a newspaper, magazine or other publication, book, notice, circular, pamphlet, letter, handbill, poster, sign, placard, label, tag, window display, store sign, radio, television announcement, Internet, or other means or methods employed to bring to the attention of the public the practice of selling or fitting hearing aids.
Audiologist--A person who holds a current license as an audiologist issued by the State Board of Examiners in Speech-Language and Hearing, or a person who is permitted to practice audiology pursuant to an exemption to the audiologist licensure requirement under section 6(b) of the Speech-Language and Hearing Licensure Act (63 P. S. § 1706(b)).
Authorized representative--A person who is authorized by law to make a decision, required pursuant to this subchapter, for a hearing aid user or prospective hearing aid user.
Business of selling hearing aids--
(i) Selling, leasing or offering for sale or lease new, used or reconditioned hearing aids exclusive of parts, attachments or accessories, at retail, either as exact replacements for damaged or worn out units or written specifications provided by an audiologist, otologist or otolaryngologist.
(ii) The term does not include fitting or the practice of fitting and selling hearing aids.
Continuing education program--A program approved by the Department for credit towards the continuing education requirements for the renewal of the registration certificate of a hearing aid fitter.
Conviction--A plea or verdict of guilty, or a conviction following a plea of nolo contendere to a charge of a crime involving moral turpitude.
Department--The Department of Health of the Commonwealth.
Fitting--Includes the physical acts of adjusting the hearing aid to the individual, taking audiograms, making ear molds, advising the individual with respect to hearing aids, making audiogram interpretations and assisting in the selection of a suitable hearing aid to sell a hearing aid.
Hearing aid--A wearable instrument or device designed or offered to aid or compensate for impaired human hearing together with any parts, attachments or accessories for those instruments or devices, including ear molds but excluding batteries and cords.
Hearing aid dealer--A person engaged in the business of selling hearing aids.
Hearing aid fitter--An individual engaged in the practice of fitting and selling hearing aids.
Hearing aid user--An individual who uses a hearing aid.
Practice of fitting and selling hearing aids--Those practices used solely for making selections, adaptations and sales of hearing aids.
Prospective hearing aid user--An individual who is considering buying a hearing aid or whose hearing is being evaluated by a registrant.
Purchaser--An individual who has agreed to purchase a hearing aid from a registrant.
Registrant--A hearing aid dealer or fitter holding a current certificate of registration.
Secretary--The Secretary of Health of the Commonwealth.
Sponsor--An individual registered in this Commonwealth as a hearing aid fitter who agrees to supervise an apprentice hearing aid fitter.
Used hearing aid--
(i) A hearing aid that has been worn for any period of time by a user.
(ii) A hearing aid is not a used hearing aid if it has been worn only by a prospective user as part of a bona fide hearing aid evaluation conducted in the presence of the registrant or an individual selected by the registrant and authorized by law to assist the prospective user in making such an evaluation.
§ 25.203. Advisory Council.
(a) The Advisory Council (Council) will be composed as provided for under section 201 of the act (35 P. S. § 6700-201).
(b) It will be the duty of the Council to advise the Secretary, to the best of its ability, on the administration of the act.
(c) The Council will hold at least one annual meeting at a time and place designated by the Secretary for the purpose of providing information and advice to the Department.
(d) A Council member may convey the impression, either publicly or privately, that the member is acting officially for the Council only with prior authorization from the Council.
§ 25.204. Application for and renewal of registration.
(a) Application. An application for registration or renewal of registration as a hearing aid dealer, hearing aid fitter, apprentice hearing aid fitter or temporary hearing aid fitter can be obtained from the Division of Home Health, Pennsylvania Department of Health, 132 Kline Plaza, Suite A, Harrisburg, Pennsylvania 17104.
(b) Apprentice hearing aid fitter. A completed application for registration as an apprentice hearing aid fitter shall be filed with the Department at least 30 days before the fitter's examination that the applicant intends to take, together with a check, money order or other approved method of payment as the Department publishes in a notice in the Pennsylvania Bulletin, in the amount of $50. An additional $150 shall be paid before taking the fitter's examination. The application fee is not refundable, but the $150 fee for the examination will be refunded to an applicant who is found to be ineligible to take the examination.
(c) All other registrations. A completed application for any registration certificate, other than a registration certificate as an apprentice hearing aid fitter, may be filed at any time, together with a check, money order or other approved method of payment as the Department publishes in a notice in the Pennsylvania Bulletin, in the amount of the appropriate application fee.
(d) Renewal of current certificate. A registrant shall apply to renew a current registration certificate by March 16 prior to the certificate's expiration, by submitting a completed renewal application, available from the Department, along with the renewal fee of $100. To renew a hearing aid fitter's registration certificate, the applicant shall also demonstrate satisfaction of the continuing education requirements under § 25.216 (relating to continuing education requirements).
(e) Renewal of expired certificate. An expired registration certificate may be renewed within 5 years after its expiration or inactive date by filing an application for renewal, with payment of the renewal fee, and payment of the delinquency fee if the application is received more than 30 days after the expiration date. To renew an expired hearing aid fitter's registration certificate, the applicant shall also demonstrate satisfaction of the continuing education requirements under § 25.216.
(f) Renewal of fitter's temporary registration certificate and apprentice certificate. Upon application, the Secretary may renew a temporary certificate or apprentice certificate for a period which shall expire 30 days after the next available fitter's qualifying examination has been given. The Secretary will not issue more than two renewals of these certificates, except upon petition of an applicant for good and sufficient cause shown. An applicant may petition the Department for an additional renewal. The petition shall include the reasons for which the additional renewal is requested. An applicant shall send a petition for additional renewal to the Division at the address given in subsection (a). The Department will then decide whether to issue the renewal.
(g) Late application for renewal. A person who files for renewal of a registration certificate after March 16 may not receive the renewal before the registration certificate expires.
§ 25.205. Additional registration requirements.
(a) Hearing aid dealers. No requirement is imposed in addition to those imposed under § 25.204(c) (relating to application for and renewal of registration).
(b) Hearing aid fitters. A hearing aid fitter shall pass the qualifying examination as provided by the act.
(c) Reciprocal registration--certificate by endorsement.
(1) An applicant for registration to practice as a hearing aid dealer or as a hearing aid fitter who is licensed or registered in any other state, which has requirements equal to or greater than those in this Commonwealth for registration as a hearing aid dealer or fitter and which maintains reciprocal practice privileges with this Commonwealth, may be granted a registration certificate by endorsement by the Secretary. Being qualified to apply for a hearing aid fitter's registration certificate by endorsement relieves the applicant from having to take the qualifying examination otherwise required under the act.
(2) In all other respects, the applicant for a registration certificate by endorsement shall be registered in the same manner and meet the same requirements as other registrants.
(3) If the Commonwealth does not maintain reciprocal practice privileges with a state in which a person is registered or otherwise authorized to function as a hearing aid fitter or dealer, the person may apply for a temporary registration certificate under subsection (e).
(d) Apprentice registration. Apprentice registration shall conform to the following:
(1) An applicant for registration as an apprentice hearing aid fitter shall have a sponsor responsible for the training and supervision of the applicant.
(2) An application shall be accompanied by a statement of the sponsor:
(i) Setting forth the type of supervision which shall be given the applicant.
(ii) Providing an outline of the training program to be followed in preparing the applicant for examination. The training program shall include education and training in at least the following areas:
(A) The anatomy and physiology of the ear.
(B) The function of hearing aids.
(C) The grounds for revocation or suspension of a certificate of registration, or probation of a registrant, under the act.
(D) The violations and penalties under the act.
(E) The procedures and use of equipment established by the Department for the fitting and selling of hearing aids.
(F) The taking of ear mold impressions.
(G) The medical and rehabilitation facilities for children and adults that are available in the areas served.
(H) The criteria for medical referral when found to exist either from observation by the registrant or on the basis of information furnished by the prospective hearing aid user, to include those criteria in § 25.211(d) (relating to medical recommendations; waiver forms).
(iii) Providing the registration number of the sponsor.
(3) An apprentice hearing aid fitter desiring to change sponsors shall furnish the Department a sworn or affirmed request giving reasons for the change and a sworn or affirmed statement from the new sponsor setting forth the information required by paragraph (2), and accompanied by the apprentice's certificate of registration. An affirmed statement may be given in any form so long as it is in writing, signed, and contains a statement to the effect that it is truthful.
(4) A sponsor desiring to terminate responsibilities with regard to an apprentice shall give the apprentice 10 days written notice of the reasons for the action and shall notify the Department at the same time by certified mail.
(e) Temporary registration. Temporary registration shall conform to the following:
(1) A temporary fitter's registration certificate will be issued to an applicant who satisfactorily demonstrates having been engaged in the fitting and selling of hearing aids at an established place of business in a state other than this Commonwealth for 2 years within a 5-year period immediately before making application and who otherwise fulfills the requirements of the act and this subchapter.
(2) The temporary registrant shall take the hearing aid fitter's examination to qualify for a regular hearing aid fitter's registration certificate.
(3) The temporary registration certificate shall expire 30 days after the administration of the qualifying examination that the temporary registrant takes. The temporary registrant shall take the qualifying examination no earlier than 90 days after the date the temporary registration certificate was issued, and no later than 1 year after the date the temporary registration certificate was issued.
§ 25.206. Examinations.
(a) An examination to obtain registration as a hearing aid fitter shall be held at least twice each year, at a time and place to be fixed by the Secretary at least 45 days before the examination date.
(b) The date of an examination may be obtained by writing to the Division at the address given in § 25.204(a) (relating to application for and renewal of registration), by checking the Department's website at www.health.state.pa.us, or by phone or e-mail to the Division.
(c) The passing grade on an examination will be determined by the Secretary.
§ 25.207. Categories of registrations; fee schedule.
(a) A registration certificate, other than a temporary or apprentice registration certificate, shall expire at midnight of April 15 of each year, if not renewed.
(b) For a hearing aid dealer, the initial registration fee is $200 if the Department issues the registration certificate between April 15 and October 14, and $100 if the Department issues the registration certificate between October 15 and April 14. The annual renewal fee is $100 for both dealers and fitters.
(c) For a hearing aid fitter's registration certificate, the initial registration fee is $200, $150 of which will be refunded if the applicant is ineligible to take the qualifying fitter's examination. The annual renewal fee is $100.
(d) For a registration certificate by endorsement the fees shall be the same as in subsection (b).
(e) For a temporary hearing aid fitter's registration certificate, the initial registration fee is $200, $150 of which is for the examination. A refund of the $150 will be made if the applicant is ineligible to take the qualifying examination for a fitter's registration certificate. Instead of paying the full $200 when making the application, the applicant may pay $50 when making the initial application, and $150 before taking the examination for the first time. The renewal fee is $100.
(f) For an apprentice fitter's registration certificate, the fee is $50 plus an additional $150 before the apprentice takes the fitter's examination. The renewal fee is $100.
(g) For a duplicate or replacement registration certificate, the fee is $10. The registrant shall obtain a duplicate certificate upon the loss of an original certificate or for a branch office. The registrant shall obtain a replacement registration certificate upon a name change by the person holding a certificate.
(h) The fee to retake the fitter's examination for an applicant who has previously failed the examination is $50.
(i) A delinquency fee will be assessed if an applicant applies for renewal of a registration certificate after May 15. The delinquency fee is $50.
(j) For renewal of a suspended registration certificate, the fee is $100 plus the delinquency fee if one has otherwise accrued.
§ 25.208. Display of registration certificates; offices.
(a) A registrant shall display the dealer's or fitter's registration certificate at the place of business listed in the registrant's application.
(b) If a registrant maintains more than one place of business within this Commonwealth, the registrant shall apply for a duplicate registration certificate for each branch office. The registrant shall display the appropriate duplicate registration certificate in each office.
(c) The place of business identified in a registrant's application shall be an office at a fixed location. An office which is part of a building normally used as a residence shall be in a space set aside for office purposes only.
(d) A registrant shall file notice of a change in the registrant's place of business with the Department at least 10 work days before the change by writing to the Department at the address given in § 25.204(a) (relating to application for and renewal of registration).
(e) A registrant shall make the registration certificate available for inspection on request of any client, prospective client, Department employee or law enforcement official.
§ 25.209. Facilities, procedures and instrumentation.
(a) Facilities. A registrant shall engage in the practice of fitting or selling a hearing aid only if the registrant provides:
(1) An appropriate test area, the ambient noise level of which shall have a documented readout of 55 dB or lower on the A scale of a sound level meter.
(2) A selection of hearing aid models, supplies and accessories to provide for the immediate needs of hearing aid users or prospective hearing aid users.
(b) Procedures. A registrant shall satisfy the following:
(1) The registrant shall sell a hearing aid only if within 6 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. This requirement does not apply when the registrant is replacing a hearing aid with another of the same make, model and response. The registrant shall sell a hearing aid replacing another of the same make, model and response only if within 12 months before the sale an examination of the prospective hearing aid user was conducted using pure tone air conduction, bone conduction and speech audiometry tests. The registrant shall verify that the tests were performed by an individual authorized by law to do so. The registrant may rely on a representation by the physician, audiologist or fitter who performed or supervised the tests that the individual who performed the tests was authorized to do so.
(2) The registrant shall:
(i) Perform air conduction tests for hearing level thresholds at frequencies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and 6,000 Hz or 8,000 Hz, with masking if necessary.
(ii) Perform bone conduction tests for hearing level thresholds at frequencies of 500 Hz, 1,000 Hz, 2,000 Hz and 4,000 Hz, with masking if necessary.
(iii) Maintain records of the test results for each ear for 7 years.
(iv) Perform a speech reception or speech awareness threshold test using an electronic speech audiometer with head or insert ear phones.
(v) Perform a word discrimination or other speech intelligibility test for conversational level speech using an electronic speech audiometer with head or insert ear phones.
(3) The registrant shall sell a hearing aid only if the hearing aid is fitted to the wearer to ensure physical and operational comfort and improvement in hearing function is demonstrated and documented in at least one of the following areas: speech detection, speech awareness levels, speech intelligibility, orientation or speech reception threshhold.
(c) Instrumentation. A registrant shall satisfy the following:
(1) All test instruments shall be calibrated once each year or more often if necessary to meet current American National Standards Institute standards for pure tone and speech audiometry as identified by 1996 A.N.S.I. standards or applicable succeeding A.N.S.I. standards.
(2) Instruments transported to test sites shall be calibrated to the standard set forth in paragraph (1) every 6 months, or more frequently as needed.
(3) Calibration shall be performed by a qualified individual other than the owner.
(4) A signed certificate identifying the most recent date of calibration shall be maintained for inspection by the Department.
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