Proposed Rule Establishing Over-the-Counter (OTC) Hearing Aids
Released October 20, 2021
This side-by-side comparison is intended to summarize the recommendations put forth in the consensus paper drafted by the hearing care associations (ASHA, AAA, ADA, & IHS) in 2018 and the FDA-proposed regulations released in October 2021. ASHA submitted comments to the FDA on January 13, 2022, urging them to consider several revisions that would strengthen and ensure consumer safety and device efficacy.
| Hearing Care Associations Paper | FDA-Proposed Regulations | |
|---|---|---|
| Intended Users | Individuals 18 y/o + with self-perceived mild to moderate hearing loss (defined as thresholds of 26 - 55 dB HL for product design requirements) | Individuals 18 y/o + with self-perceived mild to moderate hearing loss; functional descriptors of mild to moderate hearing provided |
| Definition of OTC Hearing Aids | Name the new category of devices “Self-Fit Over-the-Counter Hearing Devices” | Category labeled as “Over-the-Counter Hearing Aids;” they may be “self-fit” but this not a requirement |
| Output Limit; Gain Requirements | Peak OSPL90 no greater than 110dB SPL; 25 dB gain limit | Max OSPL90 limit of 115 dB SPL or 120 dB SPL if device is equipped with a volume control & input controlled compression; no gain requirement |
| Design Requirements | Input-controlled compression; volume control; only instant-fit eartips should be used | Input-controlled compression & volume control acknowledged as beneficial but NOT required; earpiece must use atramuatic materials and sit no deeper than the bony-cartiaginous junction of ear canal. |
| Labeling Outside the Box | Recognition of intended use/usage; important notice about hearing loss being a medical condi- tion best addressed in consultation with a licensed professional | Warning against use in people younger than 18; symptoms of mild to moderate hearing loss; advice of availability of professional services; “red flag” conditions that require medical care; weblink and telephone number for information; notice of manufacturer’s return policy |
| Labeling Inside the Box | Strong warning against use in children; user instructional brochure with direction on how to identify lack of benefit and what to do | Warning against use in people younger than 18; “red flag” conditions that require medical care; warning about pain from device placement; cautions about hearing protection and excessive sound output; advice to seek professional services; note about user expectations; note about reporting adverse effects to FDA; information about use and care of devices; technical data |
| Risk Classification | Same risk classification as hearing aids: Class I - non-wireless, Class II - wireless, manufacturer should be required to undergo 510(k) process | Class I - legacy air-conduction hearing aids and Class II -wireless air–conduction hearing aids are exempt from 510(k) process; Class II self-fitting air–conduction hearing aids are not 510(k) exempt; prescription devices would no longer be restricted devices |
| Consumer Protection | Return and refund policies; protection against unsubstantiated and false claims | Not proposing to federally mandate a return policy for OTC devices; however, state or local requirements for returns would likely continue to apply; protections against misbranding under FD&C Act - violations subject to enforcement action |
