Skip to content

Lyric Hearing Aid

by Insound Medical, Inc.

510(k) K081136

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081136 Date8 May 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1681-2010 FDA Unclassified (pre-2012) initiated 19 Jan 2010

    Manufacturing error could result in electrolyte leakage from the product's battery.

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  • Withdrawn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

Other devices from Insound Medical, Inc.