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Newsletter: FDA Makes Critical Clarification to Final OTC Hearing Aid Rule

The Agency makes clear the rule does not change the qualifications required for hearing health professionals who may provide hearing healthcare for patients requiring prescription hearing aids

This week, the Food and Drug Administration (FDA) made an important clarification regarding provisions that are critical to hearing health professionals in their final OTC hearing aid rule that was issued in August of 2022.

Through a letter provided to state officials, the FDA writes: “The final rule defining non-OTC hearing aids as prescription devices does not, and is not intended to, create barriers to accessing hearing aids, including prescription devices. It does not require the involvement of different or additional health care providers or examinations upon the effective date.” 

This important clarification comes after hearing healthcare industry partners raised concerns with the FDA regarding language that could be interpreted as limiting patient access to prescription hearing aids and requiring the involvement of additional healthcare professionals in providing patients a prescription. 

We are pleased the FDA listened carefully and made this critical clarification to ensure that the OTC rule will not hinder hearing health professionals’ ability to help their patients needing prescription devices.

While this letter provides important guidance to states regarding the FDA’s intent with the final rule, we will continue to monitor activity happening at the state level that may impact hearing healthcare. As always, there may be more advocacy work to be done to protect patient safety and we will continue to provide additional information as it is available.

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