The Upcoming Issuance of the OTC Hearing Aid Proposed Rule

With the beginning of a new year we look forward to FDA’s issuance of the OTC Hearing Aid Proposed Rule on or before  August 2020 as defined by Congress.  We recognize the huge workload assigned to an Agency that regulates 20 cents of every dollar spent by U. S. consumers. For this reason, the articulate, transparent and focused program of the FDA on the OTC Hearing Aid should continue unbated.

The resultant rule will affect tens of millions of Americans and their families. .  A recent report published by the World Health Organization concludes that: “ Overall, this cautious analysis suggests that the annual cost of unaddressed hearing loss is in the range $750-790 billion globally.”

Senators Question FDA on OTC Hearing Aid Regulations

Regulatory Focus

Posted 09 December 2019 | By Michael Mezher 

Senators Question FDA on OTC Hearing Aid Regulations

In a letter to Acting US Food and Drug Administration (FDA) Commissioner Brett Giroir last week, Senators Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) raised questions about the agency’s plans to issue rules to regulate over-the-counter (OTC) hearing aids.

“Hearing aids can greatly assist those with hearing loss to lead normal lives. 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, noting that many Americans with age-related hearing loss are unable to afford hearing aids.

Current State of Benefit-Cost Analysis on Traditional Hearing Aids

In brief, the current state of benefit-cost analysis on traditional hearing aids is modest but sufficient for the World Health Organization to conclude in 2017 that “Provision of hearing devices is a cost-effective strategy, especially when used regularly and supported with rehabilitation services.” The WHO report did recommend that additional data on the topic be developed: “Country-specific data on the cost of unaddressed hearing loss and cost–effectiveness of interventions should be gathered to strengthen available evidence.”

An Appeal to Federal Regulators:  WebMD on Over the Counter Hearing Aids

WebMd has conducted an in-depth report on forthcoming Over the Counter Hearing Aids.  Their conclusions include:

“…… costs and hurdles are what led to the passage of a federal law in 2017 that designates a new FDA-regulated category for over-the-counter (OTC) hearing aids. But OTC hearing aids, which will be approved to treat mild to moderate hearing loss in adults ages 18 and older, aren’t here just yet. The FDA has until August 2020 to publish proposed guidelines for OTC hearing aids.”

FDA Letter to Hearing Aid Manufacturers

Editor’s Note: Attached is a July 2018 letter from the US FDA to hearing aid manufacturers which discusses the mandate for the agency to establish a new category of OTC hearing aids. The FDA letter notes that until the agency publishes final OTC hearing aid regulations “no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids….”

From: US FDA

Dear Hearing Aid Manufacturer:

In section 709 of the FDA Reauthorization Act of 2017 (FDARA), Congress enacted a definition, outlined certain requirements, and set forth a process for establishing a category of over-the-counter (OTC) hearing aids and the requirements that apply to them.

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

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

Federal Trade Commission Workshop on Hearing Health Care

Editor’s Noted: In April 2017, the Federal Trade Commission (FTC) held a workshop “Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care” in which government and industry stakeholders discussed how developments in hearing aids relates to the FTC’s responsibilities. The workshop included discussion of the costs and benefits of hearing health care regulations.

From: FTC Workshop

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Study: A Cost–Benefit Analysis of Hearing Aids, Including the Benefits of Reducing the Symptoms of Dementia

Editor’s: Attached is a 2019 cost-benefit analysis of hearing aids. The study estimates that the global cost of unaddressed hearing loss is almost $800 billion/year. The study also found that “the total benefits, mainly coming from the direct benefits, were around a quarter of a million dollars and very large relative to the costs, with a benefit–cost ratio of around 30.” The study “results confirm the findings in the literature
that HAs [hearing aids] reduce the symptoms of dementia.”

From: A cost–benefit analysis of hearing aids, including the benefits of reducing the symptoms of dementia, Applied Economics, 51:28, 3091-3103, DOI:
10.1080/00036846.2018.1564123