Dive Brief:

• Two powerful Senate lawmakers who helped author the Over-the-Counter Hearing Aid Act pressed FDA in a letter publicly released Monday to update Congress on why it has not yet published a proposed rule establishing a new category of hearing aids to expand access to the devices.
• Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Sen. Elizabeth Warren, D-Mass., noted FDA previously said it planned to issue the regulations in November 2019, according to its Unified Agenda, but has yet to take action.
• FDA spokesperson Kristen Pluchino told MedTech Dive the Unified Agenda timeline "is not intended to be a precise estimate," but noted the agency remains "committed to implementing this provision."

Dive Insight:

The legislation, which was passed into law as part of the FDA Reauthorization Act of 2017, requires FDA to issue a proposed rule establishing an over-the-counter hearing aid category by August 2020, and then finalize it no later than 180 days after the public comment period closes.

"The agency is committed to implementing this provision, and to ensuring the proper guardrails are in place to make over-the-counter hearing aids a safe and effective option for consumers," Pluchino said.

The hearing industry has actively lobbied for friendly regulations that maintain the role audiologists play in the marketplace, with one firm, Starkey Hearing Technologies, spending more than $1.27 million since the start of 2017. The industry argues hearing aids are devices that need to be tuned by professionals for patient safety.

And in May, the Hearing Industries Association called into question the clinical studies underlying FDA's decision to grant marketing authorization to Bose's self-fitting hearing aid in a letter to the agency.

Warren and Grassley's offices both told MedTech Dive they are simply performing normal oversight to ensure the law is properly implemented, when asked if they received signs FDA delaying its rulemaking.

"Sen. Grassley is a strong proponent of congressional oversight, and as it was his bill with Sen. Warren, he's simply working to ensure the law is carried out as intended," Grassley spokesperson Michael Zona said.

The senators' letter, sent to FDA late last week, notes that only 14% of the 48 million Americans who experience age-related hearing loss can currently afford hearing aids.

"Sadly, although hearing aids are considered prescription products, they are not generally covered by health insurance or Medicare and can cost thousands of dollars," Grassley and Warren wrote. "For seniors or those on limited budgets, at these prices, hearing aids may not be obtainable."

The senators asked FDA for an update by Dec. 19 on the status of the over-the-counter hearing aid regulations and when the agency plans to publish final rulemaking.