N.Y. General Business Law § 798: Business practice; requirements

§ 798. Business practice; requirements. 1. Every registrant who

engages in the dispensing of hearing aids shall have and maintain a

principal office or place of business. Each registrant shall report to

the secretary the address of each such office or place of business at

which he or she engages in such dispensing. Changes in address shall be

reported within thirty days.

2. Except as limited by the provisions of this article, each

registrant shall conspicuously post a valid individual certificate of

registration in open view within his or her office or place of business

at all times.

3. A hearing aid dispenser who is the owner, manager, or franchisee at

a location where hearing aids are dispensed, shall be responsible for

the dispensing of any hearing aid at that location.

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:

(a) a relevant personal history questionnaire;

(b) a disclosure statement;

(c) requirements for a testing room, if applicable;

(d) requirements for the annual calibration and maintenance of

audiometric equipment;

(e) requirements for out of office dispensing of hearing aids; and

(f) if applicable, requirements otherwise provided under article one

hundred fifty-nine of the education law.

5. (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.

(b) A replacement of an identical hearing aid within one year shall be

an exception to such requirement.

(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:

(a) take no action to encourage, in any way, the prospective user to

waive such a medical or audiological evaluation;

(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";

(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;

(d) review the contents of such brochure with the prospective user

orally;

(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

(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.

7. No hearing aid dispenser shall verbally or in writing make a

statement or reference to a prospective hearing aid user regarding any

medical condition or medical diagnosis.

8. It is unlawful for a registered hearing aid dispenser to dispense a

hearing aid unless he or she has first:

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

(b) inquired and made general observations for any of the following

conditions:

(i) visible congenital or traumatic deformity of the ear;

(ii) history of, or active drainage from the ear within the previous

ninety days;

(iii) history of sudden or rapidly progressive hearing loss within the

previous ninety days;

(iv) acute or chronic dizziness;

(v) unilateral hearing loss of sudden or recent onset within the

previous ninety days;

(vi) audiometric air-bone gap equal to or greater than fifteen

decibels at 500, 1000, and 2,000 hertz (hz);

(vii) visible evidence of bleeding, significant cerumen accumulation,

or a foreign body in the ear canal; and

(viii) pain or discomfort in the ear.

(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:

(a) complied with all provisions of state laws and regulations

relating to the dispensing of hearing aids; and

(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. (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".

(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:

(a) the date of consummation of the sale;

(b) specifications as to the make, serial number, and model number of

the hearing aid or aids sold;

(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;

(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;

(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;

(f) the terms of any written warranty, as required by this article;

(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.";

(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".

(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.

(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.

(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. (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.

(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.

(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:

(a) results of the hearing test, fitting, selection, sales, rental and

adaptation or service practices as required under this article;

(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

(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:

(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;

(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

(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."

16. No registered hearing aid dispenser, trainee or an employee of the

registered hearing aid dispenser or trainee, shall canvass from house to

house for the purpose of selling or renting a hearing aid. No registered

hearing aid dispenser or trainee shall personally visit the home of a

prospective customer for the purpose of selling or renting a hearing aid

without the prior request of the prospective customer.

17. No registered hearing aid dispenser, manufacturer, organization or

distributor shall sell or rent a hearing aid to a resident of this state

through direct mail order sales.

18. No registered hearing aid dispenser or trainee shall conduct or

consummate the sale of a hearing aid over the telephone unless the

prospective user has been tested by that dispenser within the previous

thirty days or a hearing aid user has initiated a request for a

replacement of a specific hearing aid.

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:

(a) a hearing aid will not restore normal hearing;

(b) any hearing test or examination is not a medical test or

examination and is solely for the purposes of fitting a hearing aid;

(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

(d) the costs of testing or office visits; and, the range of costs of

hearing aids available from the registered hearing aid dispenser.

20. A registered hearing aid dispenser shall distribute printed

educational information approved by the secretary to prospective hearing

aid purchasers about the general use of hearing aids and assistive

listening devices and on the advantages and disadvantages of binaural

hearing aids, as well as rights and remedies available to the consumer

pursuant to this article.