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Resound Personal Hearing System Bt-P W/Phs Bt-P

by Resound Corp.

510(k) K931942

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The RESOUND PERSONAL HEARING SYSTEM BT-P W/PHS features a proprietary sound processing technology that enhances clarity and reduces background noise, making it an effective solution for individuals with hearing loss or tinnitus. Available in various styles and prescription options, this device is designed to provide accurate sound reproduction for daily life.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931942 Date20 Jul 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ESD
Device Class
Class I
Regulation
21 CFR Part 874.3300
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

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