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.”