[32 Pa.B. 3223]
[Continued from previous Web Page]
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. [These §§ 25.201--25.215] This sub- chapter (relating to hearing aid sales and registration) [apply] applies to all persons engaged in the business of selling or fitting hearing aids in this Commonwealth; [provided however] except that physicians[, surgeons,] and audiologists are exempted from all provisions regarding hearing aid fitters.
(b) Authority. [These §§ 25.201--25.215 (relating to hearing aid sales and registration) are issued pursuant to] This subchapter is adopted under the act [262].
§ 25.202. Definitions.
The following words and terms, when used in [these §§ 25.201--25.215 (relating to hearing aid sales and registration) shall have] this subchapter have the following [meaning] meanings, unless the context clearly indicates otherwise:
Act [262]--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 [any] other means or methods [now or hereafter] employed to bring to the attention of the public the practice of selling or fitting hearing aids.
Audiologist--A person [holding the Certificate of Clinical Competence in Audiology awarded by the American Speech and Hearing Association or any person who can provide evidence to the Secretary of having successfully completed equivalent academic training and clinical experience] 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 under 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 under this subchapter, for a hearing aid user or prospective hearing aid user.
Business of selling hearing aids--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 [pursuant to] written specifications provided by an audiologist, otologist[,] or otolaryngologist; but not including fitting or the practice of fitting and selling [of] 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 [made] to a charge of a crime involving moral turpitude.
* * * * * 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 [interpretation,] interpretations and assisting in the selection of a suitable hearing aid [for the sole purpose of the sale of] to sell a hearing aid.
Hearing aid--[Any] A wearable instrument or device designed or offered [for the purpose of aiding or compensating] to aid or compensate for impaired human hearing together with any parts, attachments[,] or accessories for [such device] those instruments or devices, including ear molds but excluding batteries and cords.
Hearing aid dealer--[Any] A person engaged in the business of selling hearing aids.
Hearing aid fitter--[Any] An individual engaged in the practice of fitting and selling hearing aids.
Physician--An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.
* * * * * Registrant--A hearing aid dealer or fitter holding a current certificate of registration.
* * * * * Sponsor--[A] An individual registered in this Commonwealth as a hearing aid fitter who agrees to supervise an apprentice hearing aid fitter.
Used hearing aid--A hearing aid that has been worn for any period of time by a user. 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 [262] (35 P. S. § 6700-201).
(b) It will be the duty of the [Advisory] Council to advise the Secretary, to the best of its ability, on the administration of [Act 262] the act.
(c) [Meetings of the Advisory Council will be as follows:
(1)] The Council will hold at least one annual meeting at [the] a time and place designated by the Secretary for the purpose of providing information and advice to the Department.
[(2) Each Council member will be notified of scheduled meetings at least four weeks in advance; however, special or emergency meetings may be scheduled on shorter notice.]
(d) [No] A Council member [shall] may convey the impression, either publicly or privately, that [such] the member is acting officially for the [council without] Council only with prior authorization from the [council] Council.
§ 25.204. Application for and renewal of registration.
(a) Application. [Application] An application for registration or renewal of registration as a hearing aid dealer, [as a] hearing aid fitter, [as an] apprentice hearing aid fitter[,] or [as a] temporary hearing aid fitter can be obtained from the Division of [Drugs, Devices and Cosmetics, Pennsylvania] Home Health, Department of Health, [P. O. Box 90,] 132 Kline Plaza, Suite A, Harrisburg, Pennsylvania [17120] 17104.
(b) [Hearing] Apprentice hearing aid fitter. [Completed applications] A completed application for registration as [a] an apprentice hearing aid fitter shall be filed with the Department at least 30 days [prior to] before the [schedule] fitter's examination [date] that the applicant intends to take, together with a check [or], money order or other approved method of payment as the Department publishes in a notice in the Pennsylvania Bulletin, in the amount of [the required application fee] $50. An additional $150 shall be paid before taking the fitter's examination. The application fee is not refundable [except to applicants], but the $150 fee for the examination will be refunded to an applicant who [are] is found to be ineligible to take the examination[, in which case a $75 refund will be made].
(c) All other registrations. [Completed applications] 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 [or], 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. [Prior to] At least 30 days before the expiration of [any] a registration certificate, a registrant may apply to renew that certificate by submitting a completed renewal [applications] application, available from the Department, along with the renewal fee of [$50] $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 [at any time] within 5 years after its expiration 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 [certificates] certificate and apprentice [certificates] 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.
(g) Late application for renewal. A person who files for renewal of a registration certificate less than 30 days before the expiration of the registration certificate may not receive the renewal before the registration certificate expires.
§ 25.205. [Special application] Additional registration requirements.
(a) Hearing aid dealers. No [additional requirements need be met] requirement is imposed in addition to those imposed under § 25.204(c) (relating to application for and renewal of registration).
(b) Hearing aid fitters. [Hearing] A hearing aid [fitters] fitter shall pass the qualifying examination as provided by [Act 262] the act.
(c) Reciprocal registration--certificate [of] by endorsement.
(1) [Applicants] An applicant for registration to practice as a hearing aid dealer or as a hearing aid fitter who [are] is licensed or registered in any other state, which has requirements equal to or [higher] greater than [Pennsylvania] those in this Commonwealth for registration as a hearing aid dealer or fitter and which maintains reciprocal practice privileges with Pennsylvania, may be granted a registration certificate [of] by endorsement by the Secretary [which]. 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 [Act 262] the act.
(2) In all other respects, the applicant for a registration certificate [of] by endorsement shall be registered in the same manner and meet the same requirements as other registrants.
(3) If Pennsylvania 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 [with] to the following:
(1) [Applicants] An applicant for registration as an apprentice hearing aid fitter shall have a sponsor responsible for the training and supervision of the [apprentice trainee] applicant.
(2) [Applications] An application shall be accompanied by a statement of the sponsor:
(i) Setting forth the type of supervision which shall be given the [trainee] applicant.
(ii) Providing an outline of the training program to be followed in preparing the [trainee] 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 listed in § 25.211(d) (relating to medical recommendations; waiver forms).
(iii) Providing the registration number of the [employer who shall be licensed as a hearing aid fitter in this Commonwealth] sponsor.
(3) [A trainee] 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 [trainee's apprentice] apprentice's certificate of registration.
(4) A sponsor desiring to terminate responsibilities with regard to an apprentice shall give the apprentice 10 days written notice [giving] 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 [with] to the following:
(1) [An] A temporary fitter's registration certificate will be issued to an applicant who [proves to the satisfaction of the Department that he has] satisfactorily demonstrates having been engaged in the fitting and selling of hearing aids at an established place of business in a state other than [Pennsylvania] this Commonwealth for [a period of] 2 years within a 5-year period immediately [prior to his] before making application and who otherwise fulfills the requirements of [Act 262] the act and [these §§ 25.201--25.215 will be issued a temporary fitter's registration certificate] this subchapter.
(2) The temporary registrant [must] 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 [no later than] 30 days after the administration of the qualifying examination [given not earlier than 90 days after the issuance of the certificate but not later than one year from the date of issue, whichever comes sooner] 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) [Examinations for] An examination to obtain registration as a hearing aid [fitters' registration certificates] fitter shall be held at least twice each year, at a time and place to be fixed by the Secretary[,] at least 45 days [in advance of] before the examination date.
(b) The date of [the examinations] an examination may be obtained by writing to the Department.
(c) The passing grade on [the] an examination will be determined by the Secretary.
§ 25.207. Categories of registrations; fee schedule.
(a) [Regular] A registration [certificates] 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 [dealers] dealer, the initial registration fee [shall be $100. From October 15 through April 14, the fee shall be $50] 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 [shall be $50] is $100 for both dealers and fitters.
(c) For a hearing aid [fitters] fitter's registration certificate, the initial registration fee [shall be $100, $75] is $200, $150 of which will be refunded if the applicant is [found to be] ineligible to take the qualifying fitters' examination. [From October 15 through April 14, the fee shall be $50.] The annual renewal fee [shall be $50] is $100.
(d) For a registration [by reciprocity] certificate [of] by endorsement, the fees shall be the same as in [subsections (a) and] subsection (b)[, as applicable].
(e) For a temporary hearing aid fitter's registration certificate, the initial registration fee [shall be $100, $75] is $200, $150 of which [will be refunded] is for the examination. A refund of the $150 will bemade if the applicant is [found to be] 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 [shall be $50] is $100.
(f) For an apprentice fitter's registration certificate, the fee shall be [$25] $50 plus an additional [$75 prior to taking the qualifying] $150 before the apprentice takes the fitter's examination. The renewal fee [shall be $50] is $100.
(g) For a duplicate or replacement registration certificate, the fee shall be [$5.00] $10. [A] The registrant shall obtain a duplicate certificate [shall be issued] upon the loss of an original certificate[,] or for a branch office[, or]. 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 [applicants] an applicant for a fitter's registration certificate who [have] has failed a previous examination [shall be $25] is $50 for each succeeding examination.
(i) A delinquency fee will be assessed if an applicant applies for renewal of a registration certificate more than 30 days after the registration certificate has expired. The delinquency fee [shall be $25] is $50.
(j) For renewal of a suspended registration certificate, the fee [shall be $50] is $100 plus the delinquency fee if one has otherwise accrued.
§ 25.208. Display of registration certificates; offices.
(a) [Each hearing aid dealer or fitter] A registrant shall display [his] the dealer's or fitter's registration certificate at the place of business listed in the registrant's application.
(b) [Offices which are part of a building normally used as a residence shall be in a space set aside for office purposes only.] 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) [Whenever a registrant desires to move his place of business, notice of the change shall be filed with the Department within 10 working days of such a change.] 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) [When a hearing aid fitter's or temporary hearing aid fitter's registration certificate is issued and on each renewal thereof, the Department will issue a card bearing the expiration date to the registrant, who shall keep it in his possession at alltimes during the performance of duties.] 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.
(e) [The] A registrant shall make the registration certificate [or card, or both, shall be] available for inspection on request of any client, prospective client, Department employe[,] or [peace officer] law enforcement official.
§ 25.209. Facilities, procedures and instrumentation.
(a) Facilities. [No] A registrant shall engage in the practice of fitting or selling a hearing aid [unless he] only if the registrant provides:
(1) An appropriate test area, the ambient noise level of which [must] shall have a documented readout of 55 dB or lower on the A scale of a sound level [matter] meter.
(2) A selection of hearing aid models, supplies[,] and accessories to provide for the immediate needs of [clients] hearing aid users or prospective hearing aid users.
(b) Procedures. [Procedures] A registrant shall [conform with] satisfy the following:
(1) [A] The registrant shall sell a hearing aid [shall not be sold unless] only if within 6 months [of] before the sale an examination of the [client] prospective hearing aid user was conducted using pure tone air conduction, bone conduction[,] and speech audiometry tests [has been conducted, or], except 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. [Such] The registrant shall verify that the tests [shall be] were performed by [a physician, surgeon, audiologist, or registered fitter or by an individual supervised by any of the aforementioned persons] an individual authorized by law to do so.
(2) The [fitter] registrant shall[, as a minimum]:
(i) Perform air [conductor] 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 [where] if necessary.
(ii) Perform bone conduction tests for hearing level thresholds at frequencies of [250 Hz,] 500 Hz, 1,000 Hz, 2,000 Hz[,] and 4,000 Hz, with masking [where] if necessary.
(iii) Maintain records of the test results for each ear for [a period of] 7 years.
(iv) Perform a speech reception or speech awareness threshold test using an electronic speech audiometer [under] with head or insert ear phones[; additional testing may be performed with other sound pressure instruments as needed].
(v) Perform a word discrimination or other speech intelligibility test for conversational level speech using an electronic speech audiometer [under] with head or insert ear phones.
(3) [No registered hearing aid fitter] The registrant shall [fit and] sell a hearing aid [to any individual unless the instrument] only if the hearing aid is fitted to the wearer [so as] to [insure] ensure physical and operational comfort and [unless documented] improvement in hearing function is demonstrated and documented in [one or more] at least one of the following areas[;]: speech detection, speech awareness levels, [sensitivity] speech intelligibility, orientation or [SRT changes] speech reception threshhold.
(c) Instrumentation. [Instrumentation shall conform with] A registrant shall satisfy the following:
(1) All test instruments shall be calibrated [at least] 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 A.N.S.I. S3.6-1969 or as identified in [revised forms] succeeding A.N.S.I. standards.
(2) Instruments transported to test sites shall be calibrated to the standard set forth in paragraph (1) [at least] every 6 months, or more frequently as needed.
(3) Calibration [will be] shall be performed by a qualified individual other than the owner.
(4) A signed certificate [indicating] identifying the most recent date of calibration shall be maintained for inspection by the Department.
§ 25.210. Receipt, disclosure agreement and money back guarantee to purchaser--purchaser protection.
(a) Receipt. Upon the sale of [any] a hearing aid, the registrant shall provide the purchaser a signed receipt [containing]. The receipt may be made out on more than one sheet of paper and shall contain the following:
* * * * * (2) The make, model[,] and serial number or, if no serial number is applicable, an identification number of the hearing aid.
* * * * * (4) If the hearing aid is used or reconditioned, a statement which [indicates that fact] provides that information and which meets the requirements of § 25.215(23) (relating to denial, revocation[,] or suspension of registrant's certificate).
* * * * * (7) A copy of the written forms as required by § 25.211 (relating to medical recommendations; waiver forms).
(8) A statement on or attached to the receipt, in no smaller than 10 point type, as follows: ''The purchaser has been advised at the outset of his relationship with the hearing aid dealer that any examination or representation made by a registered hearing aid dealer and fitter in [conjunction] connection with the practice of fitting and selling of this hearing aid, is not an examination, diagnosis[,] or prescription by a person licensed to practice medicine in this Commonwealth and therefore must not be regarded as medical opinion.''
(9) A statement on the face of the receipt, in no smaller than 10 point bold type, as follows: ''If your rights are violated, you may contact the State Bureau of Consumer Protection [or], the Pennsylvania Department of Health in Harrisburg, or your local district attorney.''
(b) Disclosure agreement and money back written guarantee. Before the provision of any service incidental to or connected with the potential sale of a hearing aid, the registrant shall provide a disclosure agreement and money back written guarantee to the prospective hearing aid user or authorized representative. This shall be in 10 point type or larger, and may be made out on more than one sheet of paper, but shall employ the following format:
(Editor's Note: The following form is proposed to be added. It is printed in regular type to enhance readability.)
HEARING AID DISCLOSURE AGREEMENT/MONEY BACK GUARANTEE
(Business Name) _________________ (Business Address) _________________
Telephone No. ( ) ______PART A.
Description of services included in
fitting procedure or process, and
sale and delivery of hearing aid.
FEE (State
whether fee is
waived if hearing
aid purchased)REFUNDABLE
(Upon return of hearing aids)
NOT
REFUNDABLE
PART B.
HEARING AIDS &
ACCESSORIESDESCRIPTION of
GOODS--include make,
model, serial number(s)PRICE REFUNDABLE
(upon return of
hearing aid)NOT
REFUNDABLE
(Cancellation Fee)Hearing Right Aid(s) Left Accessories (Describe,
if applicable)TOTAL Total maximum Cancellation Fee is lesser of 10% or $150 per hearing aid including accessories. I RECEIVED THIS DISCLOSURE AGREEMENT, AND IT WAS EXPLAINED TO ME, INCLUDING PART A, FEES FOR SERVICES THAT ARE NOT PART OF THE PRICE OF THE HEARING AID, AND PART B, CANCELLATION FEES THAT WILL BE INCURRED IF I RETURN A HEARING AID FOR A REFUND UNDER THE 30 DAY MONEY BACK GUARANTEE BELOW, AT ______ (time) ON _________________ (date), BEFORE ANY SERVICES WERE PROVIDED.
_________________
Customer's Signature30 Day Money Back Guarantee: If a hearing aid is returned within 30 days of date of delivery in the same condition, ordinary wear and tear excluded, you are entitled to a refund of the portion of the purchase price of the hearing aid and accessories as itemized on the receipt and above, less the cancellation fee stated above. If a cancellation fee is imposed, the nonrefundable amount for each aid and accessories cannot exceed 10% of the purchase price of the hearing aid and accessories or $150.00 per aid and accessories, whichever is less. You will, however, be responsible for all nonrefundable service fees listed in Part A. If you cancel your order prior to delivery, you are entitled to full refund of the purchase price of the aid and accessories, and a full refund for services not yet rendered.
_________________
Customer's Signature_________________
Date and time of Sale_________________
DATE of DELIVERY_________________
Registrant's Signature_________________
Registration Number_________________
Customer's Signature or Initials(c) Additional responsibilities of registrant with respect to the disclosure agreement/money back guarantee.
(1) The registrant shall fill in the appropriate spaces on the disclosure agreement/money back guarantee. The registrant shall include in Part A a complete description of what the fitting procedure or process includes, and shall itemize and disclose fees associated with the fitting procedure or process and the sale and delivery of the hearing aid. For each service provided, the registrant shall identify by dollar amount the portion of the fee that is refundable and the portion that is not refundable. If a fee will be waived if a hearing aid is purchased, that shall be stated. If the registrant charges no fees for services, Part A may be left blank.
(2) The registrant shall itemize in Part B any cancellation fee associated with the sale and delivery of a hearing aid and its accessories, by designating that amount as ''not refundable.''
(3) The registrant may revise the relevant portion of the disclosure agreement/money back guarantee form to disclose the registrant's policy of offering a money back guarantee return period longer than 30 days. The money back guarantee shall be for at least 30 days.
(4) The registrant shall explain in detail the entire disclosure agreement/money back guarantee to the prospective hearing aid user or authorized representative, before securing the signature of the purchaser.
(5) The registrant shall ensure that the prospective hearing aid user or authorized representative signs the disclosure agreement/money back guarantee under Part B, before the registrant provides any service incidental to the possible sale of a hearing aid to the prospective hearing aid user.
(6) The registrant shall ensure that the purchaser signs the bottom portion of the disclosure agreement/money back guarantee, directly under the money back guarantee provision, and inserts the date and time of sale on the appropriate line, after the decision to purchase a hearing aid is made.
(7) At the time the hearing aid is delivered to the hearing aid user or authorized representative, the registrant shall ensure that the signature or initials of the user or authorized representative is obtained and the date of delivery is inserted in the block provided for that purpose on the disclosure agreement/money back guarantee. After the block is completed with the initials or signature and date, the registrant shall provide a copy of the completed disclosure agreement/money back guarantee to the purchaser.
§ 25.211. [Waiver] Medical recommendations; waiver forms.
(a) [Where a client wishes to waive a medical examination] Except when selling a replacement of a worn out or damaged hearing aid, when selling a hearing aid for the use of a prospective hearing aid user who is 18 years of age, a registrant shall either obtain for the prospective user a medical recommendation that complies with § 25.212 (relating to medical recommendations by examining physicians), or ensure that the prospective user or authorized representative signs a waiver form as provided under section 403 of the act [262] (35 P. S. § 6700-403) [a]. The waiver form [must] shall be prepared and used as follows:
(1) The waiver form [must] shall be in 10 point type or larger.
(2) The waiver [must] shall be read to the [client] prospective hearing aid user or authorized representative and explained in a manner [such] so that the [client] individual is not encouraged to waive a medical examination and so that the [client] individual will be thoroughly aware that signing the waiver will not be in [his] the prospective hearing aid user's best interest.
(3) The waiver form shall read as follows:
I have been advised that my best [interest] interests would be served if I had a medical examination by an otologist or otolaryngologist or any licensed physician before my purchase of a hearing aid.
__________
(Registrant's Name)has fully and clearly informed me of the value of such medical examination. After such explanation, I voluntarily [signed] sign this waiver[,]. I choose not to seek a medical examination [for] before the purchase of the hearing aid.
__________
(Signature of [registrant] Registrant)
__________
(Address of [registrant] Registrant)
__________
(Signature of Purchaser)
__________
(Date of Signature)(b) [The waiver set forth in subsection (a)(3) may not be used for any person 18 years of age or younger or for individuals having any of the following conditions.
(1) Visible congenital or traumatic deformity of the ear.
(2) Active drainage from the ear within the previous 90 days of history of this symptom.
(3) Sudden or rapidly progressive hearing loss within the previous 90 days of history of this symptom.
(4) Acute or chronic dizziness.
(5) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(6) Visible evidence of cerumen accumulation or a foreign body in the ear canal.
(7) Significant air-borne gap, when generally acceptable standards have been established.
(8) Pain in the ear within the previous 90 days.]
When selling a replacement of a worn out or damaged hearing aid for the use of a prospective hearing aid user who is 18 years of age or older, a registrant shall either obtain for the prospective user a medical recommendation that complies with the requirements of § 25.212, or ensure that the prospective user or authorized representative signs a legally proper waiver of the medical examination.
(c) [Subsection (b) shall not be enforced until such time as the Food and Drug Administration of the United States Department of Health, Education, and Welfare acts upon the Department of Health's application for exemption from preemption of less stringent Federal requirements on the same subject. The FDA has proposed to grant that exemption in a notice of proposed rule making found at 43 Fed. Reg. 33,180 (1970).] Except when a registrant is selling a hearing aid to replace an identical hearing aid, the registrant may sell a hearing aid for the use of a prospective user 18 years of age or younger only if the registrant obtains a medical recommendation that complies with the requirements of § 25.212 and is signed by a physician specializing in otolaryngology or otology. When selling an identical replacement hearing aid for the use of an individual under 18 years of age, the registrant shall obtain a medical recommendation that complies with § 25.212.
(d) Before the sale of a hearing aid, a registrant shall inform the prospective hearing, aid user or authorized representative, in writing, that it would be in the best interest of the prospective hearing aid user to consult a physician specializing in or qualified to deal with diseases of the ear if the prospective hearing aid user has any of the following conditions:
(1) Visible congenital or traumatic deformity of the ear.
(2) Active drainage from the ear within the previous 90 days or a history of this symptom.
(3) Sudden or rapidly progressive hearing loss within the previous 90 days or a history of this symptom.
(4) Acute or chronic dizziness.
(5) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(6) Visible evidence of cerumen accumulation or a foreign body in the ear canal.
(7) Significant air-bone gap of 15dB or greater at 500 Hz, 1000 Hz and 2000 Hz.
(8) Pain in the ear within the previous 90 days.
§ 25.212. Medical recommendations by examining physicians.
(a) Whenever a medical examination is performed [pursuant to] under the act [262] or Federal requirements, before fitting and selling a hearing aid the registrant shall ensure that a medical recommendation [shall be] has been signed by the examining physician, within 180 days before the sale, on a form which includes the following statement or its equivalent:
I have medically evaluated the hearing ability of
__________
([patient's name] Patient's Name)and a hearing aid may be beneficial to this person.
__________
(Signature of [physician] Physician)
__________
(Date of Evaluation)(b) [Where] If the [client] prospective hearing aid user is 18 years of age or younger, the [patient's] registrant shall ensure that the prospective user's date of birth [shall be] has been included on the medical recommendation form.
[(c) Such form will be valid for up to 6 months from the date of signature.]
§ 25.213. Consumer review.
(a) Before signing [any statement] a waiver form under § 25.211 (relating to medical recommendations; waiver forms) and before the sale of [any] a hearing aid to or for the use of a prospective hearing aid user, the [hearing aid fitter or dealer] registrant shall:
(1) Provide the prospective hearing aid user or authorized representative with a copy of the User Instructional Brochure for the hearing aid that has been or may be selected for the prospective user.
(2) Review the content of the User Instructional Brochure with the prospective hearing aid user or authorized representative orally or in the predominant method of communication used during the sale.
(3) Give the prospective hearing aid user or authorized representative an opportunity to read the User Instructional Brochure.
(b) [Where] If goods or services having a sale price of $25 or more are sold or contracted to be sold to a [buyer] purchaser as a result of or in connection with a contact with or call on the [buyer] purchaser at [his] the purchaser's residence, the [consumer] purchaser may avoid the contract or sale by notifying[, in writing,] the [seller] registrant of that decision, in writing, within 3 full business days following the day on which the contract or sale was made and by returning or holding available for return to the [seller] registrant, in its original condition, any merchandise received under the contract or sale. [Such] The notice of rescission [shall be] is effective [upon depositing the same] when deposited in the United States mail or [upon other] when service is made in another manner which gives the [seller] registrant notice of rescission.
(c) Additional provisions relating to the sale of goods in the [buyer's] purchaser's home, including specific items[,] which [must] shall be included on the receipt, are hereby made a part of this section[,] by [Incorporation] incorporation of section 7 of the Unfair Trade Practices and Consumer Protection Law (73 P. S. § 201.7).
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