Innerscope Hearing Technologies Inc (INND)

[GREAT WHITE]

Response from FDA


Dear John

Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) [e-mail] e-mail account.

Establishing an over-the-counter category for hearing aids is a priority for the FDA and we are working hard to review and respond to the many comments we received as we develop the final rule.

Unfortunately, I cannot provide a timeline for when this will be complete and final. Please continue to check our web site at https://www.fda.gov/medical-devices/consumer-products/hearing-aids for updates. Additionally, you can sign up for email updates at https://www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-email-lists


Sincerely,

Consumer Team
Division of Industry and Consumer Education
Office of Communication and Education
Center for Devices and Radiological Health
U.S. Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify DICE by email at:[e-mail] immediately.
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Original Message
From:
Sent: 6/30/2022
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Subject: OTC Hearing devices
Message:

Good morning,

Looking for an update on OTC hearing devices, this seems to be way overdue.
Hearing aids are not affordable for most, including myself.
Can someone from the FDA please post an update?
Would be greatly appreciated.

Thank you and have a great day.

Establishing an over-the-counter category for hearing aids is a priority for the FDA
$INND$