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510(k) K231550

Sontro® OTC Hearing Aids (AI) by Soundwave Hearing, LLC — Product Code QUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2023
Date Received
May 30, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Device Class
Class II
Regulation Number
874.3325
Review Panel
EN
Submission Type

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is an over the counter hearing aid. For information on the final rule “Establishing Over-the-Counter Hearing Aids,” please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.

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