§ 798 — Business practice; requirements

§ 798. Business practice; requirements. 1. Every registrant who\nengages in the dispensing of hearing aids shall have and maintain a\nprincipal office or place of business. Each registrant shall report to\nthe secretary the address of each such office or place of business at\nwhich he or she engages in such dispensing. Changes in address shall be\nreported within thirty days.\n 2. Except as limited by the provisions of this article, each\nregistrant shall conspicuously post a valid individual certificate of\nregistration in open view within his or her office or place of business\nat all times.\n 3. A hearing aid dispenser who is the owner, manager, or franchisee at\na location where hearing aids are dispensed, shall be responsible for\nthe dispensing of any hearing aid at that location.\n 4. The secretary shall in consultation with the hearing aid advisory\nboard prescribe the minimum criteria, procedures and equipment which\nshall be used in the dispensing of hearing aids, including but not\nlimited to:\n (a) a relevant personal history questionnaire;\n (b) a disclosure statement;\n (c) requirements for a testing room, if applicable;\n (d) requirements for the annual calibration and maintenance of\naudiometric equipment;\n (e) requirements for out of office dispensing of hearing aids; and\n (f) if applicable, requirements otherwise provided under article one\nhundred fifty-nine of the education law.\n 5. (a) Unless otherwise authorized by federal law, rule or regulation,\nno hearing aid shall be sold by a hearing aid dispenser under this\narticle, to any person, unless that person provides the dispenser with a\nwritten statement from an otolaryngologist, or if none is available by\nanother licensed physician stating that the prospective user's hearing\nloss has been medically evaluated and that the prospective user is a\ncandidate for a hearing aid.\n (b) A replacement of an identical hearing aid within one year shall be\nan exception to such requirement.\n (c) This subdivision shall not apply to any individual over the age of\nsixteen who has within the preceding three years been examined by an\notolaryngologist, or if none was available by another licensed physician\nwho issued a medical evaluation of their hearing loss for such individ-\nual.\n 6. If it is required by federal law or regulation, a hearing aid\ndispenser shall afford to an individual, who is eighteen years of age or\nolder, the opportunity to waive the medical evaluation requirement of\nthis section, provided however, the hearing aid dispenser shall:\n (a) take no action to encourage, in any way, the prospective user to\nwaive such a medical or audiological evaluation;\n (b) prior to the performance of any activity required pursuant to\nsubdivision eight of this section and prior to the performance of any\nhearing test the hearing aid dispenser shall inform the prospective user\nthat, "Federal law requires a medical evaluation of their hearing loss.\nMedical evaluation shall be conducted by an otolaryngologist, or if none\nis available, by another licensed physician. You have the right to waive\nthis requirement. You must sign a statement of waiver of your rights if\nyou elect to do so";\n (c) provide the prospective user with a copy of the manufacture's user\ninstructional brochure for a hearing aid that has been or may be\nselected for the prospective user;\n (d) review the contents of such brochure with the prospective user\norally;\n (e) conspicuously post a sign in at least forty point bold-faced type\nwhich states: "Federal law requires a medical evaluation of your hearing\nloss by an otolaryngologist, or if none is available, by another\nlicensed physician. You have the right to waive this requirement. If you\nwaive this requirement, you must sign a statement of waiver of your\nrights". Such sign shall also indicate the toll-free number required\nunder section eight hundred three of this article that individuals\nwishing to register a complaint can call; and\n (f) should the prospective user elect to waive his or her rights, the\nprospective user shall sign the following advisory statement:\n "I have been advised by (hearing aid dispenser's name) that the Food\nand Drug Administration has determined that my best health interest\nwould be served if I had a medical evaluation by a licensed physician\n(preferably a physician specializing in diseases of the ear) before\npurchasing a hearing aid. I do not wish a medical evaluation before\npurchasing a hearing aid. I have also been advised that although the\nexamination conducted by (hearing aid dispenser's name) reveals no\nindicators mandating referral to a licensed physician, preferably one\nspecializing in diseases of the ear, for medical evaluation as required\nby law, it is in my best health interest to be examined by a physician\nspecializing in diseases of the ear for any medical condition or disease\nat least once every three years."\n If the prospective user is or the parent or guardian of any person\nunder the age of eighteen years is a member of any church or religious\ndenomination whose tenets and practices include reliance upon spiritual\nmeans through prayer alone and objects to medical treatment and so\nstates in writing to the hearing aid dispenser or hearing aid trainee,\nsuch individual shall undergo a hearing examination as provided by this\nsection, but no proof, ruling out any medically treatable problem\ncausing hearing loss, shall be required.\n 7. No hearing aid dispenser shall verbally or in writing make a\nstatement or reference to a prospective hearing aid user regarding any\nmedical condition or medical diagnosis.\n 8. It is unlawful for a registered hearing aid dispenser to dispense a\nhearing aid unless he or she has first:\n (a) conducted a direct observation of the purchaser's ear canals;\n (b) inquired and made general observations for any of the following\nconditions:\n (i) visible congenital or traumatic deformity of the ear;\n (ii) history of, or active drainage from the ear within the previous\nninety days;\n (iii) history of sudden or rapidly progressive hearing loss within the\nprevious ninety days;\n (iv) acute or chronic dizziness;\n (v) unilateral hearing loss of sudden or recent onset within the\nprevious ninety days;\n (vi) audiometric air-bone gap equal to or greater than fifteen\ndecibels at 500, 1000, and 2,000 hertz (hz);\n (vii) visible evidence of bleeding, significant cerumen accumulation,\nor a foreign body in the ear canal; and\n (viii) pain or discomfort in the ear.\n (c) Whenever any of the conditions listed in paragraph (b) of this\nsubdivision is found to exist, no hearing aid dispenser shall dispense a\nhearing aid to such prospective user. The hearing aid dispenser shall\nadvise the prospective user of the observed condition and shall advise\nhim or her to promptly consult a licensed physician, preferably a\nspecialist in diseases of the ear. The prospective user shall be advised\nthat he or she may consult with another licensed physician, if no\notolaryngologist is available. A hearing aid dispenser may dispense a\nhearing aid to such prospective user after such user has obtained a\nmedical clearance. No prospective user may waive medical evaluation\nunder this subdivision if any of the conditions listed in paragraph (b)\nof this subdivision is found to exist except that a prospective user or\nthe parent or guardian thereof may request a waiver on the basis that\nmedical treatment violates his or her religious tenets or beliefs. A\nhearing aid dispenser shall read to and then present a waiver to such\nprospective user or parent or guardian thereof which shall provide: "at\nmy request, (name of hearing aid dispenser) has informed me that I may\nwaive medical evaluation of my hearing due to my personal religious\nbeliefs, signed (name of prospective user or parent or guardian)." No\nhearing aid dispenser shall seek to induce a prospective user or parent\nor guardian of a prospective user to execute a waiver in order to effect\nthe sale of a hearing aid.\n 9. It is unlawful for a registered hearing aid dispenser to dispense a\nhearing aid unless he or she has first:\n (a) complied with all provisions of state laws and regulations\nrelating to the dispensing of hearing aids; and\n (b) has informed the purchaser of the address and office hours at\nwhich the registrant shall be available for fitting or post-fitting\nadjustments and servicing of the hearing aid or aids sold.\n 10. (a) A hearing aid dispenser, not otherwise licensed pursuant to\narticle one hundred fifty-nine of the education law, shall provide any\nprospective hearing aid users with a copy of their audiogram which shall\ninclude puretone (air and bone conduction) and speech audiometry test\nresults, upon completion of such audiometric tests. Such audiogram shall\nclearly and conspicuously contain the following statement: "This\ninformation is intended for the sole purpose of fitting or selecting a\nhearing aid and is not a medical examination or audiological\nevaluation".\n (b) Hearing aid dispensers licensed under article one hundred\nfifty-nine of the education law shall comply with the provisions of such\narticle in the conduct of audiological evaluations and shall further\nprovide a copy of the results of any audiological evaluation to any\nprospective hearing aid users with the following statement: "This is an\naudiological evaluation and is not a medical examination".\n 11. A registrant shall, upon the consummation of a sale of a hearing\naid, deliver to the purchaser a written receipt or purchase agreement,\nsigned by the purchaser, the registrant and if applicable, the trainee,\ncontaining all of the following:\n (a) the date of consummation of the sale;\n (b) specifications as to the make, serial number, and model number of\nthe hearing aid or aids sold;\n (c) the address of the principal place of business of the registrant,\nand the office hours available for fitting or post-fitting adjustments\nand servicing of the hearing aid or aids sold;\n (d) a statement to the effect that the hearing aid or aids delivered\nto the purchaser are used or reconditioned, as the case may be;\n (e) the number of the registrant's certificate and the name and\nregistration number of any other hearing aid dispenser or trainee who\nprovided any recommendation or consultation regarding the purchase of\nthe hearing aid;\n (f) the terms of any written warranty, as required by this article;\n (g) such receipt shall bear, or have attached to it in no smaller than\nfourteen point type, the following: "The purchaser has been verbally\nadvised at the outset of his or her relationship with the registered\nhearing aid dispenser that any examination or representation made by a\nhearing aid dispenser in connection with the business of dispensing this\nhearing aid, or hearing aids, is not an examination, diagnosis, or\nprescription by a person licensed to practice medicine in this state,\nand therefore, must not be regarded as medical opinion.";\n (h) such written receipt or purchase agreement shall also outline the\npurchaser's right to return as required by subdivision twelve of this\nsection. (i) The receipt shall include, in immediate proximity to the\nspace reserved for the signature of the buyer, the following statement\nin all capital letters of no less than twelve point bold-faced type: "IN\nADDITION TO OTHER RIGHTS, THE BUYER HAS THE RIGHT TO CANCEL THIS\nPURCHASE FOR ANY REASON AT ANY TIME PRIOR TO TWELVE MIDNIGHT OF THE 45TH\nCALENDAR DAY ( ) AFTER RECEIPT OF THE HEARING AID AND RETURN THE HEARING\nAID IN THE SAME CONDITION, ORDINARY WEAR AND TEAR EXCLUDED. BY LAW, THE\nSELLER IS ALLOWED TO RETAIN AN AMOUNT UP TO TEN PERCENT OF THE TOTAL\nPURCHASE PRICE OF THE CANCELLED HEARING AID, INCLUDING BATTERIES AND\nCORDS OR ACCESSORIES THERETO, INCLUSIVE OF ALL FEES RELATED TO THE\nHEARING AID".\n (ii) If the dispenser is a not-for-profit hospital or facility\nlicensed or certified pursuant to article twenty-eight of the public\nhealth law, the receipt shall include, in immediate proximity to the\nspace reserved for the signature of the buyer, the following statement\nin all capital letters of no less than twelve point bold-faced type: "IN\nADDITION TO OTHER RIGHTS, THE BUYER HAS THE RIGHT TO CANCEL THIS\nPURCHASE FOR ANY REASON AT ANY TIME PRIOR TO TWELVE MIDNIGHT OF THE 45TH\nCALENDAR DAY ( ) AFTER RECEIPT OF THE HEARING AID AND RETURN THE HEARING\nAID IN THE SAME CONDITION, ORDINARY WEAR AND TEAR EXCLUDED. BY LAW, THE\nDISPENSER IS ALLOWED TO RETAIN AN AMOUNT UP TO FIVE PERCENT OF THE TOTAL\nPURCHASE PRICE OF THE CANCELLED HEARING AID, INCLUDING BATTERIES AND\nCORDS OR ACCESSORIES THERETO, INCLUSIVE OF ALL FEES RELATED TO THE\nDISPENSING OF THE HEARING AID, PLUS A SERVICE FEE OF NOT MORE THAN TWO\nHUNDRED DOLLARS, UNLESS A SECOND HEARING AID WAS FITTED AND DISPENSED AT\nTHE SAME TIME AS THE FIRST, THEN SUCH FEE SHALL NOT EXCEED THREE HUNDRED\nDOLLARS FOR BOTH HEARING AIDS."\n 12. No hearing aid shall be sold to any person unless accompanied by a\nforty-five calendar day money-back written guarantee.\n (a) If an individual returns a hearing aid in the same condition,\nordinary wear and tear excluded, within the guarantee period, the\ncustomer shall be entitled to the return of the cost of the hearing aid\nand accessories as itemized on the receipt provided pursuant to\nsubdivision eleven of this section; provided however that any hearing\naid that has been used for a forty-five calendar day period as described\nin this subdivision, when refinished and totally reconditioned by the\nmanufacturer or by the manufacturer's agent and such manufacturer or\nmanufacturer's agent certifies that such hearing aid meets all the\nacoustical standards of a new hearing aid and is in all other respects\nthe equivalent of a new hearing aid and with all warranties and\nguarantees that accompany a new hearing aid, shall be considered a new\nhearing aid and so designated; and further provided, however, that a\nhearing aid dispenser shall retain as a cancellation fee for return of\nthe hearing aid, including batteries and cords or accessories thereto, a\ncharge not in excess of ten per centum of the total purchase price of\nthe cancelled hearing aid, including batteries and cords or accessories\nthereto, inclusive of all fees related to dispensing of hearing aids, as\ndefined in subdivision six of section seven hundred eighty-nine of this\narticle. Provided, however, if the hearing aid dispenser is a\nnot-for-profit hospital or facility licensed or certified pursuant to\narticle twenty-eight of the public health law, such dispenser is allowed\nto retain an amount up to five per centum of the total purchase price of\nthe cancelled hearing aid, including batteries and cords or accessories\nthereto, inclusive of all fees related to the dispensing of the hearing\naid, plus a service fee of not more than two hundred dollars, unless a\nsecond hearing aid was fitted and dispensed at the same time as the\nfirst, then such fee shall not exceed three hundred dollars for both\nhearing aids. Such money-back guarantee as provided in this subdivision\nshall not be in lieu of or in any way affect the right of the purchaser\nto recover the full amount paid and for any damages sustained for a\nbreach of guarantee of fitness for use.\n (c) The forty-five calendar day return period shall be tolled for any\nperiod during which a hearing aid dispenser takes possession or control\nof a hearing aid after its original delivery.\n 13. (a) Within one year from the date of purchase, in addition to any\nother rights and remedies the purchaser of a hearing aid may have, the\npurchaser shall have the right to rescind the transaction if: (i) the\npurchaser consults a licensed otolaryngologist, or if no such licensed\notolaryngologist is available then another licensed physician qualified\nto diagnose diseases of the ear, subsequent to purchasing a hearing aid,\n(ii) and the physician certifies in writing that, in his or her\nprofessional judgement, at the time the dispensing occurred the\npurchaser had either a diagnosis of deafness or being hard of hearing\nfor which a hearing aid provides no benefit or had a medical condition\nwhich contraindicates the use of a hearing aid, and (iii) as the result\nof either condition, the purchaser experienced no improvement in the\nquality of hearing.\n (b) If the conditions of paragraph (a) of this subdivision are met,\nthe seller shall refund to the purchaser, within ten days of the receipt\nof notice to rescind, a full and complete refund of all moneys received,\nin compliance with paragraph (a) of this subdivision. The purchaser\nshall incur no additional liability for rescinding the transaction.\n (c) Any dispute over a purchaser's right to rescind the transaction as\nprovided in this subdivision that is not resolved administratively by\nthe department shall be determined by a court of competent jurisdiction.\n 14. A registrant shall, upon the consummation of a sale of a hearing\naid, keep and maintain records in his or her office or place of business\nat all times and each such record shall be kept and maintained for a six\nyear period. These records shall include:\n (a) results of the hearing test, fitting, selection, sales, rental and\nadaptation or service practices as required under this article;\n (b) a copy of the written receipt required by subdivision eleven of\nthis section;\n (c ) a copy of the signed written waiver, if any; and\n (d) any other material which the secretary may feel is necessary.\n 15. A registrant shall comply with applicable statutes, rules and\nregulations regarding advertising of his or her services. In addition:\n (a) no hearing aid dispenser shall, through advertisement, indicate or\nimply that any type of medical examination or audiological evaluation\nwill be provided or that the dispenser has been recommended by anyone\nother than an individual licensed to perform such examination or\nevaluation; provided, however, that nothing in this paragraph shall\nrestrict or limit any person licensed under article one hundred\nfifty-nine of the education law from performing any activity thereunder\nor from stating in an advertisement that an audiological evaluation will\nbe provided where an audiological evaluation is to be provided;\n (b) no hearing aid device, part or accessory thereof shall be\nadvertised as a new invention or involving a new mechanical or\nscientific principle unless such claim is true; and\n (c) except for those hearing aid dispensers licensed as audiologists\nunder article one hundred fifty-nine of the education law, no hearing\naid dispenser shall, through advertisement, indicate or imply that he or\nshe may perform a hearing test, examination, evaluation or consultation\nunless he or she includes the statement, "unless administered by an\naudiologist or physician, this test is for the purpose of amplification\nonly. It is not a medical test."\n 16. No registered hearing aid dispenser, trainee or an employee of the\nregistered hearing aid dispenser or trainee, shall canvass from house to\nhouse for the purpose of selling or renting a hearing aid. No registered\nhearing aid dispenser or trainee shall personally visit the home of a\nprospective customer for the purpose of selling or renting a hearing aid\nwithout the prior request of the prospective customer.\n 17. No registered hearing aid dispenser, manufacturer, organization or\ndistributor shall sell or rent a hearing aid to a resident of this state\nthrough direct mail order sales.\n 18. No registered hearing aid dispenser or trainee shall conduct or\nconsummate the sale of a hearing aid over the telephone unless the\nprospective user has been tested by that dispenser within the previous\nthirty days or a hearing aid user has initiated a request for a\nreplacement of a specific hearing aid.\n 19. If a registered hearing aid dispenser utilizes telemarketing\ntechniques or telephone contact, he or she shall comply with all\napplicable provisions of federal and state law. Any initial telephone\ncontact undertaken by a registered hearing aid dispenser or trainee\nshall include the following information:\n (a) a hearing aid will not restore normal hearing;\n (b) any hearing test or examination is not a medical test or\nexamination and is solely for the purposes of fitting a hearing aid;\n (c) if there are indications of potential medical conditions, as\ndefined by law, the prospective user will be referred to an\notolaryngologist or if none is available to a physician; and\n (d) the costs of testing or office visits; and, the range of costs of\nhearing aids available from the registered hearing aid dispenser.\n 20. A registered hearing aid dispenser shall distribute printed\neducational information approved by the secretary to prospective hearing\naid purchasers about the general use of hearing aids and assistive\nlistening devices and on the advantages and disadvantages of binaural\nhearing aids, as well as rights and remedies available to the consumer\npursuant to this article.\n