[32 Pa.B. 3223]
[Continued from previous Web Page] § 25.214. Recordkeeping.
A registrant shall, upon the consummation of a sale of a hearing aid, keep and maintain records in [his] the registrant's office or place of business at all times. These records shall be kept for 7 years and shall include the following [information]:
(1) Results of all testing conducted [pursuant to] under § 25.209 (relating to facilities, procedures and instrumentation). The minimum acceptable test records shall be records of:
(i) Pure tone tests including air and bone conduction with masking where appropriate, and the ambient noise level of the test area.
* * * * * (v) Word discrimination test results expressed in percentage indicating the test words used, presentation level, masking level (if applicable) and signal to noise ratio (if applicable).
(2) A copy of the written receipt, disclosure agreement and money back guarantee required by § 25.210 (relating to receipt, disclosure agreement and money back guarantee to purchaser--purchaser protection).
(3) The written physician's recommendation required by § 25.212 (relating to medical [recommendation] recommendations by examining physicians) or the waiver form required by § 25.211 (relating to medical recommendations; waiver forms).
§ 25.215. Denial, revocation[,] or suspension of registrant's certificate.
The Secretary may deny, suspend[,] or revoke [any] a registration certificate provided under the act [262] or [he] the Secretary may impose conditions of probation upon a registrant for any of the following causes:
* * * * * (2) Conviction of [any] a felony or misdemeanor involving moral turpitude.
* * * * * (6) Employing [any persons whose registration certificate has been suspended or who do not possess a valid registration certificate issued under act 262 to perform any function covered by the provisions of act 262] a person to perform a function within the scope of practice of a hearing aid fitter who is not authorized by law to perform the function.
* * * * * (9) Permitting another person to use the registration certificate for any purpose, except permitting an audiologist or physician employed by the registrant to sell hearing aids for the registrant.
(10) Violating or, with notice or knowledge permitting[, with notice or knowledge of its commission, the violation by any registered employee of any provision of] an employee to violate, the act [262] or [these §§ 25.201--25.215] this subchapter.
(11) [Any] A cause which would be [grounds] a ground for denial of an application for a registration certificate.
(12) Having been enjoined from violating [any provisions] a provision of the Unfair Trade Practices and Consumer Protection Law (73 P. S. §§ 201-1--209-6) or being subject to a final order of the Federal Trade Commission, the Department, or the Food and Drug Administration of the United States Department of Health, Education and Welfare, concerning the sale or offering for sale of an unsafe, unhealthful[,] or worthless hearing [devices] device or for engaging in conduct which has the tendency to mislead or deceive.
(13) Using, causing[,] or promoting the use of any advertising matter, promotional literature, testimonial, guarantee, warranty, label, brand, insignia[,] or any other representation, however disseminated or published, which is misleading, deceiving, improbable[,] or untruthful[. Included among the foregoing acts are misrepresentations], such as a misrepresentation relating to:
(i) The grade, quality, quantity, origin, novelty, price, dealer cost, terms of sale, use, construction, size, composition, dimensions, type, design, development, visibility, durability, performance, fit, appearance, efficacy, benefits, cost of operation, resistance to climatic conditions, or physiological benefits of [any] a hearing aid or the psychological well-being induced by a hearing aid[; or].
(ii) [Any] A service or adjustment offered, promised, or supplied to [purchasers] a purchaser of [any] a hearing aid, or the fee associated with the service or adjustment.
(14) Making [representations in advertising or otherwise] a representation that a hearing aid is ''guaranteed,'' without clear and conspicuous disclosure of:
(i) The nature and extent of the guarantee[;].
(ii) [Any] A material [conditions or limitations in] condition or limitation of the guarantee which [are] is imposed by the guarantor[;].
(iii) The manner in which the guarantor will perform thereunder[;].
(iv) The identity of the guarantor, with disclosure, [where] if applicable, that any guarantee made by the [dealer] registrant which is not backed up by the manufacturer is offered by the [dealer] registrant only.
* * * * * (15) Making [guarantees, warranties, or any promises] a guarantee, warranty or promise which, under normal conditions, [are] is impractical of fulfillment [or] of which [are] is for [such] a period of time or [are otherwise of such] of a nature [as may have the tendency to mislead purchasers into the belief] that may cause a purchaser to believe that the hearing aid has a greater degree of service ability, durability[,] or performance capability in actual use than is [in fact] true.
(16) Making [misrepresentations] a misrepresentation as to the character of the business conducted by the registrant. Unless it is true, a [hearing aid dealer shall] registrant [shall] may not represent directly or indirectly through the use of any word or term, in [his] the corporate or trade name, in [his] advertising, or otherwise, that [he] the registrant owns or maintains a laboratory devoted to hearing [and] aid research, testing, experimentation or development[; nor shall a]. A [dealer] registrant may not misrepresent in any other material respect the character, extent[,] or type of [his] business conducted by the registrant.
(17) Causing deception that services or advice of a physician were used in the design or [manufacturer] manufacture of hearing aids. Unless it is true, a [hearing aid dealer shall] registrant may not repre-sent, directly or by implication, that the services or advice of a physician have been used in the designing or manufacturing of hearing aids. The prohibitions of this paragraph are applicable to the use of the terms ''doctor,'' ''physician,'' ''otologist[,]'' or ''otolaryngologist''; to the use of any abbreviations, variations or derivatives of [such] those terms; and to the use of any symbol, depiction, or representation having a medical connotation.
(18) Making a deceptive [representations] representation as to the visibility or the construction of a hearing aid. A [hearing aid dealer shall] registrant may not do any of the following:
* * * * * (ii) [Use in advertising, the words or expressions ''no cord,'' ''cordless,'' ''100% cordless,'' ''no unsightly cord dangling from your ear,'' ''no tell-tale wires,'' or other words or expressions of similar import unless such representations are true and unless, in close connection therewith and with equal prominence, a clear and adequate disclosure is made that a plastic tube or similar device runs from the instrument to the ear if such is the fact.
(iii) Use in advertising the words or expressions ''no button,'' ''no ear button,'' ''no buttons or receivers in either ear'' or other words or expressions of similar import unless such representations are true and unless, in close connection therewith and with equal prominence, a clear and adequate disclosure is made that an ear mold or plastic tip is inserted in the ear if such is the fact.
(iv)] Represent directly or by implication that a hearing aid utilizing bone conduction has [certain] a specified [features] feature such as the absence of anything in the ear or leading to the ear, or the like, without disclosing clearly and conspicuously that the instrument operates on the bone-conduction principle and that, in many cases of hearing loss, this type of instrument may not be suitable.
(19) Making [advertisements] an advertisement or other [representations] representation which may have the tendency or effect of misleading or deceiving [purchasers] a purchaser or prospective [purchasers into the belief] purchaser to believe that [any] a hearing aid or device or part or accessory thereof is a new invention or involves a new mechanical or scientific principle, when [such] that is not [a fact] true. Representations of the following or similar types, when not fully justified by the facts, are among those prohibited by this paragraph: ''amazing new discovery,'' ''revolutionary new invention,'' ''radically new and different,'' ''sensational new laboratory development,'' ''remarkable new electronic device,'' ''brand new invention,'' ''marvelous new hearing invention,'' ''new scientific aid[,]'' and ''miracle.''
(20) Misrepresenting the commercial nature of the registrant's business. A [hearing aid dealer shall] registrant may not represent, directly or by implication, that a commercial hearing aid establishment is a governmental or public one or is a nonprofit medical, educational[,] or research institution, through the use of [terms] a term having a medical, professional[,] or scientific connotation, such as ''Hearing Center,'' ''Hearing Institute,'' ''Hearing Bureau,'' ''Hearing Clinic,'' ''State's Hearing Clinic,'' or ''State's Speech and Hearing Center.'' Nothing in this paragraph [is meant to preclude] precludes a [hearing aid dealer] registrant from representing, if [such be the fact] true, that [he] the registrant owns, operates[,] or controls a ''Hearing Aid Center'' or from using other words or expressions which clearly and nondeceptively identify the [dealer's] registrant's establishment as a commercial hearing aid enterprise.
(21) Making a deceptive [advertisements] advertisement of a hearing aid [parts accessories] part, accessory or [components] component. A [hearing aid dealer shall] registrant may not use or cause to be used any type of advertising or promotional literature depicting or describing only a single part, accessory[,] or component of [any] a hearing aid or device, such as a battery on the finger or a transistor held in the hand, in [such] a manner [as] that may have the tendency to mislead or deceive [purchasers] a purchaser or prospective [purchasers into the erroneous belief] purchaser to believe that [such] the part, accessory[,] or component is all that [needs to] must be worn or carried.
(22) Making a deceptive [endorsements, testimonials, and so forth] testimonial or other endorsement. A [hearing aid dealer shall] registrant may not advertise or otherwise represent:
(i) That a particular individual, organization[,] or institution endorses, uses[,] or recommends [such dealer's] the registrant's hearing aids or devices when [such] that is not [a fact; or] true.
(ii) That a particular individual wears [such dealer's] the registrant's hearing aids or devices when [such] that is not [a fact] true.
(23) Making [representations] a representation either directly or indirectly that [any] a hearing aid or part thereof is new, unused[,] or rebuilt when [such] that is not [a fact. The term ''new'' shall mean a hearing aid which has not been previously sold at retail or used as a clinic demonstrator] true.
(i) In the marketing of a used hearing aid [which has been used] or a hearing aid which contains used parts, a [hearing aid dealer] registrant shall make full and nondeceptive disclosure of the fact in advertising and promotional literature relating to the product on the container, box or package in which the product is packed or enclosed. The required disclosure may be made by use of [the] words such as ''Used,'' ''Second-hand,'' ''Repaired[,]'' or ''Rebuilt,'' whichever [is applicable] applies to the product involved, and it shall appear on a tag physically attached to a hearing aid.
(ii) A [hearing aid dealer] registrant may not misrepresent the identity of the rebuilder of a hearing aid. If the rebuilding of a hearing aid was done by other than the original manufacturer, a [hearing aid dealer may not fail to] registrant shall disclose the fact wherever the original manufacturer is identified.
(24) Doing any of the following:
(i) Representing or using [seals, emblems, shields] a seal, emblem, shield or other insignia which [represent] represents, directly or by implication that a hearing aid or device has been tested, accepted or approved by an individual, concern, organization, group or association unless it is [a] true [fact] and unless the hearing aid or device has been [so] used in a manner as will reasonably [insure] ensure the quality and performance of the instrument in relation to its intended use and the fulfillment of a material [claims] claim made, implied or intended to be supported by the representation or insignia.
(ii) Representing that a hearing aid or device tested, accepted or approved by an individual, concern, organization, group or association has been subjected to [tests] a test based on a more severe [standards] standard of performance, workmanship and quality than is [in fact] true.
(iii) Making any other false, misleading or deceptive representation respecting the testing, acceptance or approval of a hearing aid device by an individual, concern, organization, group or association. It is not necessary for an individual hearing aid or device to be tested [where] if the method employed is a sample testing and full and nondeceptive disclosure of this fact is given in advertising and otherwise.
(iv) Making a false, misleading or deceptive representation regarding the practice of another registrant or the quality of a hearing aid product made by a hearing aid manufacturer, which enhances or is likely to enhance the registrant's business as a repairer, fitter or seller of hearing aids.
(25) Doing any of the following:
(i) [Imitate] Imitating or [simulate] simulating the [trademarks, trade names, brands] trademark, trade name, brand or [labels] label of [competitors] a competitor which may have the tendency or effect of misleading or deceiving [purchasers] a purchaser or prospective [purchasers] purchaser.
(ii) [Use] Using in advertising the name, model name or trademark of a particular manufacturer of hearing aids in a manner [as to imply] that implies a relationship with the manufacturer that does not exist or which otherwise may mislead or deceive [purchasers] a purchaser or prospective [purchasers] purchaser.
(iii) [Use] Using a trade name, corporate name, trademark or other designation which may have the tendency or effect of misleading or deceiving [purchasers] a purchaser or prospective [purchasers] purchaser as to the name, nature or origin of a hearing aid or of a material used therein or which is false, deceptive or misleading in another material respect.
(26) Advertising a particular model, type or kind of hearing aid for sale when [purchasers] a purchaser or prospective [purchasers] purchaser responding to the advertisement cannot purchase or [are] is dissuaded from purchasing the advertised model, type or kind, [where] if it is established that the purpose of the advertisement is to obtain prospects for the sale of a different model, type or kind than that advertised.
(i) In determining whether there has been a violation of this paragraph, consideration will be given to acts or practices indicating that the offer was not made in good faith for the purpose of selling the advertised product but was made for the purpose of contacting prospective purchasers and selling them a product or products other than that offered. Among acts or practices which will be considered in making that determination are the following:
* * * * * (E) The refusal, in the event of sale of the product offered, to deliver the product to the [buyer] purchaser within a reasonable time thereafter.
* * * * * (27) Failing to furnish evidence of the required continuing education or truthful information regarding the continuing education secured when applying for renewal of a registration certificate as a hearing aid fitter.
§ 25.216. Continuing education requirements.
(a) General requirements. Except as provided in subsection (d), the continuing education requirement for renewal of a hearing aid fitter's registration certificate is 20 hours of continuing education credit in the 2 years immediately preceding the expiration of the current registration certificate. If the applicant for renewal has had a registration certificate for less than 2 years, the required number of continuing education hours shall be calculated by prorating the number of credit hours required over a 2-year period by the number of months in which the applicant for renewal had the registration certificate which is about to expire. Only months in which the applicant had the registration certificate for at least 15 days shall be considered in the calculations.
(b) Requirements for renewal of an expired registration certificate. Except as provided in subsection (d), the continuing education requirement for renewal of a hearing aid fitter's registration certificate that has expired is 20 hours of continuing education credit in the 2 years immediately preceding the filing of the application for renewal, provided that the application for renewal is filed within 5 years after expiration of the previous registration certificate. If more than 5 years have passed since the registration certificate expired, the registration certificate may not be renewed. Instead, the individual would need to repeat the hearing aid fitter's certification examination and satisfy other requirements then in effect for an original hearing aid fitter's registration certificate.
(c) Requirements for renewal of a suspended registration certificate. The continuing education requirement for renewal of a hearing aid fitter's registration certificate which has been suspended is the same as in subsections (a) and (d). If the individual does not satisfy the continuing education requirement during the period in which the hearing aid fitter's registration certificate is suspended, the suspended registration certificate shall be considered to have expired, and the continuing education requirements in subsection (b) shall apply for renewal of the expired registration certificate.
(d) Phase-in requirements. The first 2-year period for which continuing education requirements shall be required will begin on April 15, 2003.
(e) Subject matter requirements. Any subject matter that contributes directly to the professional competence, skills and education of a hearing aid fitter is acceptable subject matter for a continuing education program. At least one half of all continuing education credit hours by which the hearing aid fitter seeks to qualify for renewal of the registration certificate shall be secured in some combination of the following core subject matter: hearing evaluation, hearing instrumentation technology, ear mold technology, hearing aid repair and maintenance, technical devices to assist the hearing-impaired, psychology of the hearing-impaired, and office procedures and compliance with the act.
§ 25.217. Approval of continuing education programs.
(a) A person may apply to the Department for approval of a continuing education program by submitting to the Department an application on a form supplied by the Department. The applicant shall supply the information requested in the application, including specification of whether the program is fully or partially devoted to any of the core subjects specified in § 25.216(e) (relating to continuing education requirements). The Department will grant approval of a continuing education program and designate whether the program is assigned full or partial credit in one of the core subjects, if the applicant satisfies the Department that the program the applicant will offer will meet the following minimum standards:
(1) The program shall be of intellectual and practical content.
(2) The program shall contribute directly to the professional competence, skills and education of a hearing aid fitter.
(3) The program instructors shall possess the necessary practical and academic skills to conduct the program effectively.
(4) Program materials shall be well written, carefully prepared, readable and distributed to attendees at or before the time the program is offered whenever practical.
(5) The program shall be presented by a qualified responsible instructor in a suitable setting devoted to the educational purpose of the program.
(6) The program shall be open to all persons who have a current, suspended or expired hearing aid fitter's registration certificate.
(b) Approval of a continuing education program shall be effective for 3 years.
(c) If renewal of the Department's approval of a continuing education program is desired, at least 90 days before expiration of the 3-year period the person who offered the program shall apply to the Department to renew the Department's approval of that program. The criteria and process applicable to the Department's initial approval of a continuing education program shall apply to renewal of the approval of that program.
§ 25.218. Credit for continuing education.
(a) Credit hour. A hearing aid fitter shall receive 1 hour of credit for each 50 minutes of instruction in a continuing education program presented in a classroom setting. Credit will not be received if attendance or other participation in the program is not adequate to meet the educational objectives of the program as determined by the person offering the program. For completing a continuing education program that is not presented in a classroom setting, the hearing aid fitter shall receive the number of credit hours assigned to the program by the Department.
(b) Program completion. A hearing aid fitter shall receive no credit for a continuing education program not completed, as evidenced by satisfaction of the check-in/check-out process for a continuing education program presented in a classroom setting and the continuing education report verifying that the hearing aid fitter completed the program, both of which are submitted to the Department by the person who offered the program. The program will also not be considered completed if the hearing aid fitter does not satisfy other program completion requirements imposed by this subchapter and the continuing education provider.
(c) Continuing education credit for instruction. A hearing aid fitter shall receive credit equal to the number of hours served as an instructor in a continuing education program approved by the Department, or in a program that satisfies requirements for initial certification as a hearing aid fitter, except that only half of the credit hours necessary for renewal of a hearing aid fitter's registration certificate may be obtained through serving as an instructor. The remaining credits necessary to renew a certificate shall be obtained through attendance at continuing education programs.
(d) Continuing education credit through endorsement. A hearing aid fitter who attends or teaches a continuing education program offered outside this Commonwealth may apply to the Department to receive credit for the program. The hearing aid fitter shall have the burden of demonstrating to the Department that the course meets standards substantially equivalent to the standards imposed in this subchapter. The Department will assign credit to the program, including the possibility of no credit or partial credit, based upon considerationsof whether the program bears entirely upon appropriate subject matter and whether the method of presenting the program meets standards substantially equivalent to those prescribed in this subchapter.
(e) Continuing education credit assigned to self-study courses. Credit may be sought from the Department for a self-study continuing education program. The hearing aid fitter shall submit an application to the Department to approve the self-study program for credit before commencing the program and shall supply the Department with the materials the Department requests to conduct the evaluation. The Department will assign credit to the program based upon considerations of whether the program addresses appropriate subject matter and whether the method of completing the program meets standards substantially equivalent to those prescribed in this subchapter. The Department may require modifications to the proposed self-study as a precondition to approving it for credit.
(f) Continuing education credit assigned to courses not presented in a classroom setting. A hearing aid fitter shall be awarded credit for completing a continuing education program without the hearing aid fitter physically attending the program in a classroom setting, provided the program has been approved by the Department for credit when presented in that manner.
(g) Repeat completion or teaching of a continuing education program. The Department will not accept more than one completion or teaching of a continuing education program for credit towards renewal of a fitter's registration certificate, but will accept a subsequent completion or teaching of the same continuing education program for a subsequent renewal of a fitter's registration certificate.
(h) Resolution of discrepancies. The Department will resolve all discrepancies between the number of continuing education credits reported and the number of continuing education credits a hearing aid fitter alleges to have earned. To help resolve disputes, the hearing aid fitter should retain the original certificate of completion of a continuing education program if a certificate of completion has been received by the hearing aid fitter.
§ 25.219. Responsibilities of persons offering continuing education programs.
(a) Record of attendance. A person who offers a continuing education program shall maintain a record of attendance for a program presented in a classroom setting by maintaining a check-in/check-out process approved by the Department, and shall assign at least one person to ensure that all individuals attending the course check in when entering and check out when leaving. If an individual enters a course after the starting time, or leaves a course before the finishing time, the assigned person shall ensure that the time of arrival or departure is recorded for the individual.
(b) Reporting attendance. A person who offers a continuing education program shall report to the Department, in the manner and format prescribed by the Department, attendance at each continuing education program presented in a classroom setting.
(c) Course evaluation. A person who offers a continuing education program shall develop and implement methods to evaluate the program to determine its effectiveness. The methods of evaluation shall include providing a program evaluation form to each person who attends the continuing education program, and requesting each person to complete the form.
(d) Record retention. A person who offers a continuing education program shall retain the completed program evaluation forms and the check-in/check-out record for a program presented in a classroom setting. The person shall retain the records for at least 4 years from the presentation of the program.
(e) Providing records. A person who offers a continuing education program shall promptly provide the Department with complete and accurate records relating to the program as requested by the Department.
(f) Program not presented in a classroom setting. A person who offers a continuing education program shall be exempt from the requirements of subsections (a) and (b) for a program which is not presented in a classroom setting, if the program is approved by the Department for credit when presented in that manner. When presenting the program to the Department for approval for credit, the person shall present a procedure for monitoring, confirming and reporting hearing aid fitter participation in a manner that achieves the purposes of subsections (a) and (b).
(g) Monitoring responsibilities. A person who offers a continuing education program shall ensure that the program was presented in a manner that met all of the educational objectives for the program, and shall determine whether each hearing aid fitter who enrolled in the program met the requirements of this subchapter and of the continuing education program to receive credit for completing the program.
(h) Program completion. A person who offers a continuing education program shall report to the Department, in a manner and format prescribed by the Department, completion of a continuing education program by a hearing aid fitter who completes the program, and shall identify to the Department a hearing aid fitter who seeks credit for a program but who did not meet the requirements of the program or this subchapter to receive continuing education credit. The person who offers a continuing education program shall also provide a hearing aid fitter who completes the program with a document certifying completion of the program.
§ 25.220. Right to enter, inspect and obtain records.
Upon request of a Department representative during regular and usual business hours, or at other times when that representative possesses a reasonable belief that a violation of this subchapter may exist, and upon the representative presenting documentation to identify himself as a representative of the Department, a registrant or person who offers a continuing education program shall:
(1) Produce for inspection equipment and supplies maintained under this subchapter.
(2) Produce for inspection, permit copying and provide within a reasonable period of time, records maintained under this subchapter.
§ 25.221. Exceptions.
The Department may grant an exception to a requirement of this subchapter for good cause shown, except for a statutory requirement that is repeated in this subchapter.
[Pa.B. Doc. No. 02-1172. Filed for public inspection July 5, 2002, 9:00 a.m.]
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