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.”

It is incumbent upon stakeholders to undertake those measures which will assist the FDA in the discharge of this important responsibility and support the Agency in completing a rulemaking process in compliance with their statutory mandate for safety and effectiveness within the Congressional deadline. These measures include expressing support for the FDA before Congressional Appropriation Committees and providing the Agency with the requisite information and analyses to assist it in the development of a notice of proposed rulemaking which complies with Executive Order 12866.

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