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NY State & Federal Law, Regulations & Professional Conduct for Hearing Aid Dispensing

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1.  In NYS, an individual hearing aid dispenser registration is required for all of the following:
  1. Non-audiologist dispenser
  2. Audiologist dispenser
  3. Administrative assistant (front office staff)
  4. Both A and B
2.  In NYS, businesses that have multiple locations and dispense hearing aids, whether they are for-profit businesses or not-for-profit corporations, are required to obtain:
  1. A business hearing aid dispensing registration only for the main office.
  2. A business hearing aid dispensing registration that must appear in each location, as well as duplicate hearing aid dispensing registrations for all staff (including trainee registrations for all AuD students and hearing aid dispensing trainees) that must appear in each location.
  3. No business license is required if all staff are audiologists.
  4. A business hearing aid dispensing registration is only required for for-profit businesses.
3.  In NYS, hearing aid dispenser registration must be renewed:
  1. Every 2 years for individuals and for each business location.
  2. Every 3 years for individuals, and for each business location.
  3. Every 4 years at the same time as audiology license renewal.
  4. Never
4.  In NYS, hearing aid dispenser registration renewal, on or after Jan. 1, 2019, includes statements affirming compliance with the performance of annual equipment calibration and test room adequacy and compliance with the following mandatory continuing education for dispensers, for audiologists, and for dually licensed clinicians:
  1. At least 1 hour of NY State and Federal Law, Rules and Regulations and Professional Conduct for Hearing Aid Dispensing and at least 2 hours of Infection Control.
  2. At least 2 hours of NY State and Federal Law, Rules and Regulations and Professional Conduct for Hearing Aid Dispensing and at least 2 hours of Infection Control.
  3. At least 1 hour of NY State and Federal Law, Rules and Regulations and Professional Conduct for Hearing Aid Dispensing and at least 2 hours of Infection Control and at least 2 of these hours must include the topic of telecoil (t-coil) and other assistive listening devices.
  4. At least 1 hour of NY State and Federal Law, Rules and Regulations and Professional Conduct for Hearing Aid Dispensing, at least 1 hour of Infection Control and at least 1 hour must include the topic of telecoil (t-coil) and other assistive listening devices.
5.  In NYS, which statement must be on the audiogram completed by an Audiologist for persons who are hearing aid candidates but have not had a medical evaluation or have no medical referral:
  1. "This is an audiological evaluation and is not a medical examination."
  2. "This information is intended for the sole purpose of fitting or selecting a hearing aid and is not a medical examination or an audiological evaluation."
  3. "This is an audiological evaluation."
  4. "This is only a comprehensive hearing examination."
6.  In NYS, which statement must be on the audiogram completed by a Hearing Instrument Dispenser for persons who are hearing aid candidates but have not had a medical evaluation or have no medical referral:
  1. "This is an audiological evaluation and is not a medical examination."
  2. "This information is intended for the sole purpose of fitting or selecting a hearing aid and is not a medical examination or an audiological evaluation."
  3. "This is a hearing test."
  4. "The person that conducted this audiogram was not an audiologist or physician."
7.  In NYS, the posting requirements include:
  1. The 40 point sign advising the need more ORL/medical evaluation.
  2. Notice of the 45 day trial.
  3. The Federal ORL/medical evaluation requirement on the purchase order.
  4. All of the above
8.  In NYS, which of the follow records pertaining to the sale of a hearing aid are among those that need to be maintained:
  1. Files for each customer including tests; fitting selection data.
  2. Sales, rentals and servicing paper work for 6 years.
  3. Correspondence from consumers & file of advertisements.
  4. All of the above
9.  In order to return a hearing aid within one year a consumer must have consulted an ORL or MD and receive a letter that certifies in writing that in his or her professional judgment, at the time the dispensing occurred the purchaser had which of the following:
  1. Financial issues arose that precluded the purchase of hearing aids.
  2. A hearing impairment for which a hearing aid provided no benefit or had a condition which contraindicates the use of a hearing aid, and experienced no improvement in quality of hearing.
  3. Changed his/her mind and no longer wanted the hearing aids.
  4. Experienced an improvement in hearing and no longer needed hearing aids.
10.  In December 2016, the FDA issued a guidance document announcing the promulgation of regulations for over-the-counter hearing aids by 2020, explaining that it does not intend to enforce the requirement that individuals 18 and up receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. How does this guidance document effect NY state laws and regulations regarding hearing aid dispensing in 2019?
  1. The recent FDA statement makes all state laws null and void.
  2. There are no changes in NY state law that requires medical evaluation and prior medical clearance prior to hearing aid use.
  3. NY state has been mandated to change its state laws to match the FDA guidance, but that mandate is not yet in effect.
  4. NY state laws and regulations now only require medical evaluation and prior medical clearance prior to hearing aid use in people under the age of 18.

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