4. The secretary shall in consultation with the hearing aid advisory board prescribe the minimum criteria, procedures and equipment which shall be used in the dispensing of hearing aids, including but not limited to:

1. (a) a relevant personal history questionnaire;
2. (b) a disclosure statement;
3. (c) requirements for a testing room, if applicable;
4. (d) requirements for the annual calibration and maintenance of audiometric equipment;
5. (e) requirements for out of office dispensing of hearing aids; and
6. (f) if applicable, requirements otherwise provided under article one hundred fifty-nine of the education law.

5.

1. (a) Unless otherwise authorized by federal law, rule or regulation, no hearing aid shall be sold by a hearing aid dispenser under this article, to any person, unless that person provides the dispenser with a written statement from an otolaryngologist, or if none is available by another licensed physician stating that the prospective user's hearing loss has been medically evaluated and that the prospective user is a candidate for a hearing aid.
2. (b) A replacement of an identical hearing aid within one year shall be an exception to such requirement.
3. (c) This subdivision shall not apply to any individual over the age of sixteen who has within the preceding three years been examined by an otolaryngologist, or if none was available by another licensed physician who issued a medical evaluation of their hearing loss for such individ- ual.

6. If it is required by federal law or regulation, a hearing aid dispenser shall afford to an individual, who is eighteen years of age or older, the opportunity to waive the medical evaluation requirement of this section, provided however, the hearing aid dispenser shall:

1. (a) take no action to encourage, in any way, the prospective user to waive such a medical or audiological evaluation;
2. (b) prior to the performance of any activity required pursuant to subdivision eight of this section and prior to the performance of any hearing test the hearing aid dispenser shall inform the prospective user that, "Federal law requires a medical evaluation of their hearing loss. Medical evaluation shall be conducted by an otolaryngologist, or if none is available, by another licensed physician. You have the right to waive this requirement. You must sign a statement of waiver of your rights if you elect to do so";
3. (c) provide the prospective user with a copy of the manufacture's user instructional brochure for a hearing aid that has been or may be selected for the prospective user;
4. (d) review the contents of such brochure with the prospective user orally;
5. (e) conspicuously post a sign in at least forty point bold-faced type which states: "Federal law requires a medical evaluation of your hearing loss by an otolaryngologist, or if none is available, by another licensed physician. You have the right to waive this requirement. If you waive this requirement, you must sign a statement of waiver of your rights". Such sign shall also indicate the toll-free number required under section eight hundred three of this article that individuals wishing to register a complaint can call; and
6. (f) should the prospective user elect to waive his or her rights, the prospective user shall sign the following advisory statement: "I have been advised by (hearing aid dispenser's name) that the Food and Drug Administration has determined that my best health interest would be served if I had a medical evaluation by a licensed physician (preferably a physician specializing in diseases of the ear) before purchasing a hearing aid. I do not wish a medical evaluation before purchasing a hearing aid. I have also been advised that although the examination conducted by (hearing aid dispenser's name) reveals no indicators mandating referral to a licensed physician, preferably one specializing in diseases of the ear, for medical evaluation as required by law, it is in my best health interest to be examined by a physician specializing in diseases of the ear for any medical condition or disease at least once every three years." If the prospective user is or the parent or guardian of any person under the age of eighteen years is a member of any church or religious denomination whose tenets and practices include reliance upon spiritual means through prayer alone and objects to medical treatment and so states in writing to the hearing aid dispenser or hearing aid trainee, such individual shall undergo a hearing examination as provided by this section, but no proof, ruling out any medically treatable problem causing hearing loss, shall be required.

8. It is unlawful for a registered hearing aid dispenser to dispense a hearing aid unless he or she has first:

1. (a) conducted a direct observation of the purchaser's ear canals;

2. (b) inquired and made general observations for any of the following conditions:

   1. (i) visible congenital or traumatic deformity of the ear;
   2. (ii) history of, or active drainage from the ear within the previous ninety days;
   3. (iii) history of sudden or rapidly progressive hearing loss within the previous ninety days;
   4. (iv) acute or chronic dizziness;
   5. (v) unilateral hearing loss of sudden or recent onset within the previous ninety days;
   6. (vi) audiometric air-bone gap equal to or greater than fifteen decibels at 500, 1000, and 2,000 hertz (hz);
   7. (vii) visible evidence of bleeding, significant cerumen accumulation, or a foreign body in the ear canal; and
   8. (viii) pain or discomfort in the ear.
3. (c) Whenever any of the conditions listed in paragraph (b) of this subdivision is found to exist, no hearing aid dispenser shall dispense a hearing aid to such prospective user. The hearing aid dispenser shall advise the prospective user of the observed condition and shall advise him or her to promptly consult a licensed physician, preferably a specialist in diseases of the ear. The prospective user shall be advised that he or she may consult with another licensed physician, if no otolaryngologist is available. A hearing aid dispenser may dispense a hearing aid to such prospective user after such user has obtained a medical clearance. No prospective user may waive medical evaluation under this subdivision if any of the conditions listed in paragraph (b) of this subdivision is found to exist except that a prospective user or the parent or guardian thereof may request a waiver on the basis that medical treatment violates his or her religious tenets or beliefs. A hearing aid dispenser shall read to and then present a waiver to such prospective user or parent or guardian thereof which shall provide: "at my request, (name of hearing aid dispenser) has informed me that I may waive medical evaluation of my hearing due to my personal religious beliefs, signed (name of prospective user or parent or guardian)." No hearing aid dispenser shall seek to induce a prospective user or parent or guardian of a prospective user to execute a waiver in order to effect the sale of a hearing aid.

9. It is unlawful for a registered hearing aid dispenser to dispense a hearing aid unless he or she has first:

1. (a) complied with all provisions of state laws and regulations relating to the dispensing of hearing aids; and
2. (b) has informed the purchaser of the address and office hours at which the registrant shall be available for fitting or post-fitting adjustments and servicing of the hearing aid or aids sold.

10.

1. (a) A hearing aid dispenser, not otherwise licensed pursuant to article one hundred fifty-nine of the education law, shall provide any prospective hearing aid users with a copy of their audiogram which shall include puretone (air and bone conduction) and speech audiometry test results, upon completion of such audiometric tests. Such audiogram shall clearly and conspicuously contain the following statement: "This information is intended for the sole purpose of fitting or selecting a hearing aid and is not a medical examination or audiological evaluation".
2. (b) Hearing aid dispensers licensed under article one hundred fifty-nine of the education law shall comply with the provisions of such article in the conduct of audiological evaluations and shall further provide a copy of the results of any audiological evaluation to any prospective hearing aid users with the following statement: "This is an audiological evaluation and is not a medical examination".

11. A registrant shall, upon the consummation of a sale of a hearing aid, deliver to the purchaser a written receipt or purchase agreement, signed by the purchaser, the registrant and if applicable, the trainee, containing all of the following:

1. (a) the date of consummation of the sale;
2. (b) specifications as to the make, serial number, and model number of the hearing aid or aids sold;
3. (c) the address of the principal place of business of the registrant, and the office hours available for fitting or post-fitting adjustments and servicing of the hearing aid or aids sold;
4. (d) a statement to the effect that the hearing aid or aids delivered to the purchaser are used or reconditioned, as the case may be;
5. (e) the number of the registrant's certificate and the name and registration number of any other hearing aid dispenser or trainee who provided any recommendation or consultation regarding the purchase of the hearing aid;
6. (f) the terms of any written warranty, as required by this article;
7. (g) such receipt shall bear, or have attached to it in no smaller than fourteen point type, the following: "The purchaser has been verbally advised at the outset of his or her relationship with the registered hearing aid dispenser that any examination or representation made by a hearing aid dispenser in connection with the business of dispensing this hearing aid, or hearing aids, is not an examination, diagnosis, or prescription by a person licensed to practice medicine in this state, and therefore, must not be regarded as medical opinion.";
8. (h) such written receipt or purchase agreement shall also outline the purchaser's right to return as required by subdivision twelve of this section. (i) The receipt shall include, in immediate proximity to the space reserved for the signature of the buyer, the following statement in all capital letters of no less than twelve point bold-faced type: "IN ADDITION TO OTHER RIGHTS, THE BUYER HAS THE RIGHT TO CANCEL THIS PURCHASE FOR ANY REASON AT ANY TIME PRIOR TO TWELVE MIDNIGHT OF THE 45TH CALENDAR DAY ( ) AFTER RECEIPT OF THE HEARING AID AND RETURN THE HEARING AID IN THE SAME CONDITION, ORDINARY WEAR AND TEAR EXCLUDED. BY LAW, THE SELLER IS ALLOWED TO RETAIN AN AMOUNT UP TO TEN PERCENT OF THE TOTAL PURCHASE PRICE OF THE CANCELLED HEARING AID, INCLUDING BATTERIES AND CORDS OR ACCESSORIES THERETO, INCLUSIVE OF ALL FEES RELATED TO THE HEARING AID".
9. (ii) If the dispenser is a not-for-profit hospital or facility licensed or certified pursuant to article twenty-eight of the public health law, the receipt shall include, in immediate proximity to the space reserved for the signature of the buyer, the following statement in all capital letters of no less than twelve point bold-faced type: "IN ADDITION TO OTHER RIGHTS, THE BUYER HAS THE RIGHT TO CANCEL THIS PURCHASE FOR ANY REASON AT ANY TIME PRIOR TO TWELVE MIDNIGHT OF THE 45TH CALENDAR DAY ( ) AFTER RECEIPT OF THE HEARING AID AND RETURN THE HEARING AID IN THE SAME CONDITION, ORDINARY WEAR AND TEAR EXCLUDED. BY LAW, THE DISPENSER IS ALLOWED TO RETAIN AN AMOUNT UP TO FIVE PERCENT OF THE TOTAL PURCHASE PRICE OF THE CANCELLED HEARING AID, INCLUDING BATTERIES AND CORDS OR ACCESSORIES THERETO, INCLUSIVE OF ALL FEES RELATED TO THE DISPENSING OF THE HEARING AID, PLUS A SERVICE FEE OF NOT MORE THAN TWO HUNDRED DOLLARS, UNLESS A SECOND HEARING AID WAS FITTED AND DISPENSED AT THE SAME TIME AS THE FIRST, THEN SUCH FEE SHALL NOT EXCEED THREE HUNDRED DOLLARS FOR BOTH HEARING AIDS."

12. No hearing aid shall be sold to any person unless accompanied by a forty-five calendar day money-back written guarantee.

1. (a) If an individual returns a hearing aid in the same condition, ordinary wear and tear excluded, within the guarantee period, the customer shall be entitled to the return of the cost of the hearing aid and accessories as itemized on the receipt provided pursuant to subdivision eleven of this section; provided however that any hearing aid that has been used for a forty-five calendar day period as described in this subdivision, when refinished and totally reconditioned by the manufacturer or by the manufacturer's agent and such manufacturer or manufacturer's agent certifies that such hearing aid meets all the acoustical standards of a new hearing aid and is in all other respects the equivalent of a new hearing aid and with all warranties and guarantees that accompany a new hearing aid, shall be considered a new hearing aid and so designated; and further provided, however, that a hearing aid dispenser shall retain as a cancellation fee for return of the hearing aid, including batteries and cords or accessories thereto, a charge not in excess of ten per centum of the total purchase price of the cancelled hearing aid, including batteries and cords or accessories thereto, inclusive of all fees related to dispensing of hearing aids, as defined in subdivision six of section seven hundred eighty-nine of this article. Provided, however, if the hearing aid dispenser is a not-for-profit hospital or facility licensed or certified pursuant to article twenty-eight of the public health law, such dispenser is allowed to retain an amount up to five per centum of the total purchase price of the cancelled hearing aid, including batteries and cords or accessories thereto, inclusive of all fees related to the dispensing of the hearing aid, plus a service fee of not more than two hundred dollars, unless a second hearing aid was fitted and dispensed at the same time as the first, then such fee shall not exceed three hundred dollars for both hearing aids. Such money-back guarantee as provided in this subdivision shall not be in lieu of or in any way affect the right of the purchaser to recover the full amount paid and for any damages sustained for a breach of guarantee of fitness for use.
2. (c) The forty-five calendar day return period shall be tolled for any period during which a hearing aid dispenser takes possession or control of a hearing aid after its original delivery.

13.

1. (a) Within one year from the date of purchase, in addition to any other rights and remedies the purchaser of a hearing aid may have, the purchaser shall have the right to rescind the transaction if: (i) the purchaser consults a licensed otolaryngologist, or if no such licensed otolaryngologist is available then another licensed physician qualified to diagnose diseases of the ear, subsequent to purchasing a hearing aid, (ii) and the physician certifies in writing that, in his or her professional judgement, at the time the dispensing occurred the purchaser had either a diagnosis of deafness or being hard of hearing for which a hearing aid provides no benefit or had a medical condition which contraindicates the use of a hearing aid, and (iii) as the result of either condition, the purchaser experienced no improvement in the quality of hearing.
2. (b) If the conditions of paragraph (a) of this subdivision are met, the seller shall refund to the purchaser, within ten days of the receipt of notice to rescind, a full and complete refund of all moneys received, in compliance with paragraph (a) of this subdivision. The purchaser shall incur no additional liability for rescinding the transaction.
3. (c) Any dispute over a purchaser's right to rescind the transaction as provided in this subdivision that is not resolved administratively by the department shall be determined by a court of competent jurisdiction.

14. A registrant shall, upon the consummation of a sale of a hearing aid, keep and maintain records in his or her office or place of business at all times and each such record shall be kept and maintained for a six year period. These records shall include:

1. (a) results of the hearing test, fitting, selection, sales, rental and adaptation or service practices as required under this article;
2. (b) a copy of the written receipt required by subdivision eleven of this section; (c ) a copy of the signed written waiver, if any; and
3. (d) any other material which the secretary may feel is necessary.

15. A registrant shall comply with applicable statutes, rules and regulations regarding advertising of his or her services. In addition:

1. (a) no hearing aid dispenser shall, through advertisement, indicate or imply that any type of medical examination or audiological evaluation will be provided or that the dispenser has been recommended by anyone other than an individual licensed to perform such examination or evaluation; provided, however, that nothing in this paragraph shall restrict or limit any person licensed under article one hundred fifty-nine of the education law from performing any activity thereunder or from stating in an advertisement that an audiological evaluation will be provided where an audiological evaluation is to be provided;
2. (b) no hearing aid device, part or accessory thereof shall be advertised as a new invention or involving a new mechanical or scientific principle unless such claim is true; and
3. (c) except for those hearing aid dispensers licensed as audiologists under article one hundred fifty-nine of the education law, no hearing aid dispenser shall, through advertisement, indicate or imply that he or she may perform a hearing test, examination, evaluation or consultation unless he or she includes the statement, "unless administered by an audiologist or physician, this test is for the purpose of amplification only. It is not a medical test."

19. If a registered hearing aid dispenser utilizes telemarketing techniques or telephone contact, he or she shall comply with all applicable provisions of federal and state law. Any initial telephone contact undertaken by a registered hearing aid dispenser or trainee shall include the following information:

1. (a) a hearing aid will not restore normal hearing;
2. (b) any hearing test or examination is not a medical test or examination and is solely for the purposes of fitting a hearing aid;
3. (c) if there are indications of potential medical conditions, as defined by law, the prospective user will be referred to an otolaryngologist or if none is available to a physician; and
4. (d) the costs of testing or office visits; and, the range of costs of hearing aids available from the registered hearing aid dispenser.