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Terminated

InSound Medical, Inc, Lyric in-canal hearing aid.

FDA Recall Z-1681-2010 · Posted 2010-05-26

Recalling FirmInSound Medical, Inc.
Recall StatusTerminated
Product CodeESD
Date Initiated2010-01-19
Date Terminated2011-08-02
Product Quantity2019 units

Reason for Recall

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

Firm Action

InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.

Root Cause

Process design

Distribution Pattern

Distribution only in US ( nationwide). No foreign consignees involved.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081136LYRIC HEARING AIDInsound Medical, Inc. · 2008-05-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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