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# Sentators Urge FDA to Allow OTC Hearing Aids
- URL: https://www.fdaweb.com/sentators-urge-fda-to-allow-otc-hearing-aids/
- Published: 2022-06-30T12:00:00.000Z
- Updated: 2026-09-14T17:50:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152215

Senators **Elizabeth Warren** (D-MA) and **Chuck Grassley** (R-IA) are putting pressure on FDA to finalize a proposed rule on making certain hearing aids available over the counter.

In a [6/29 letter](https://www.grassley.senate.gov/imo/media/doc/grassley%5Fand%5Fwarren%5Fto%5Ffda%5Fcommissioner%5F-%5Fotc%5Fhearing%5Faids%5Ffda%5Fcomment%5Freport.pdf?ref=fdaweb.com) to FDA commissioner **Robert Califf**, the lawmakers highlight findings from a Senate staff investigation on leading hearing aid manufacturers’ efforts to undermine the rule and diminish the effectiveness of over-the-counter (OTC) hearing aids. “We hope that you review our findings, which provide important context on the public comment process, and that you finalize a rule that ensures OTC hearing aids are safe, effective, accessible, and affordable for all Americans,” they said in the letter.

“Dominant hearing aid manufacturers have opposed key provisions of the FDA’s proposed rule – most notably the 120 decibels (dB) sound pressure level (SPL) output limit, the absence of a gain limit, and federal preemption requirements,” the lawmakers said. The manufacturers are also attempting to distort public perception through the public comment process, they said.

For example, Senate staff “identified what appear to be 19 industry-driven form letters, and language from these letters appeared in over 400 comments, accounting for nearly 40% of all publicly available comments that FDA received on the proposed rule,” they continued. “Although written by individuals, many of these letters used identical or nearly-identical language that either raised concerns with or recommended changes to the maximum output level, gain limit, and federal preemption requirements or any combination of the three – suggesting that they were sent as part of extensive industry-backed ‘astroturf’’ campaigns designed to give the impression of an independent grassroots response.”

The lawmakers urged Califf and FDA to “finalize a rule that is consistent with congressional intent and ensures OTC hearing aids are safe, effective, accessible, and affordable for all Americans.”