August 16, 2022executivehealthcarehearing lossOTC devicescompetition policyexecutive
FDA approves over-the-counter hearing aids 28 million Americans gain access
The FDA finalizes a rule allowing hearing aids to be sold over the counter without a prescription for adults with mild-to-moderate hearing loss, following the bipartisan Over-the-Counter Hearing Aid Act of 2017 that the Biden administration prioritized implementing. The rule takes effect October 17, 2022. Prior to the change, hearing aids required audiologist visits and prescriptions and cost $4,000 to $6,000 or more per pair. Over-the-counter devices are expected to cost a fraction of that, with some retailing below $200. The change is expected to benefit an estimated 28 million Americans with hearing loss who do not currently use hearing aids, primarily because of cost.