Regulatory Recommendations for OTC Hearing Aids from Hearing Care Associations

Editor’s Note: Attached are the consensus recommendations for OTC hearing aid safety and effectiveness from a coalition of hearing care associations including the American Academy of Audiology, the Academy of Doctors of Audiology, the American Speech-Language Hearing Association, and the International Hearing Society. The recommendation seek “to ensure safety, effectiveness and consumer protection for both intended users and unintended but foreseeable users” of OTC hearing aids.

From: Consensus Regulatory Recommendations on OTC Hearing Aid Safety & Effectiveness


Five recommendations have been identified as key to provide enough reassurance of safety
and effectiveness and of consumer protection:

1. Recommendation 1: FDA to establish product requirements appropriate for OTC
hearing devices targeting mild‐to‐moderate hearing impairment. In particular, the
Working Group recommends that: a) the 2 cc coupler HFA full on gain, as measured
at an input level of 50 dB SPL per ANSI S3.22‐2014, is 25 dB or lower; and b) the peak
(or maximum) 2 cc coupler OSPL90, per ANSI S3.22‐2014, is not greater than 110 dB
SPL, in combination with input compression and volume control. In addition, the use
of instant‐fit ear‐tips is encouraged.

2. Recommendation 2: FDA to define concise, outside‐of‐the‐box labeling appropriate
for medical devices sold over‐the‐counter. This should include recognition of
intended use / usage and an important notice for the prospective users about
hearing loss being a medical condition best addressed in consultation with a
licensed professional.

3. Recommendation 3: FDA to define comprehensive, inside‐the‐box labeling including
a strong warning that the device is not intended for children under the age of 18.
Additionally, inside‐the‐box should include a User Instructional Manual with direction
to the consumer on how to identify lack of benefit and what to do.

4. Recommendation 4: FDA to name the new category as “Self‐Fit Over‐the‐Counter
Hearing Devices” and to maintain for such category the same risk classification as air
conduction hearing aids – i.e. Class I for non‐wireless devices and Class II (exempt)
for wireless OTC hearing devices. Additionally, the Working Group strongly
recommends that any 510(k) exemptions be limited to devices that have received a
first‐time FDA marketing authorization (a 510(k) clearance). The initial OTC air
conduction hearing devices should be required to undergo the 510(k) processes.

5. Recommendation 5: FDA, in coordination with the FTC, to establish strong consumer
protection laws (e.g. return and refund policies, unsubstantiated and false claims, …)
and put in place adequate processes and resources to enforce them, especially in
the first years of introduction of the new category.

Read: Consensus Regulatory Recommendations on OTC Hearing Aid Safety & Effectiveness

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