NY Gen Bus L § 798 (2021)
2021 New York Laws GBS - General Business Article 37-A - Registration of Hearing Aid Dispensers 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.