510(K) CLEARANCES 84 ▲14 RECALLS POSTED 39 ▲27 CLASS I 6 ▲2 PMA DECISIONS 47 ▲11WEEK ENDING 2026-09-20 / FDA DATA AS OF 2026-10-05

Z-1681-2010

InSound Medical, Inc, Lyric in-canal hearing aid

Insound Medical, Inc. / initiated 2010-01-19 / Terminated / root cause: manufacturing process

InSound Medical, Inc. began a recall of InSound Medical, Inc, Lyric in-canal hearing aid on 2010-01-19. The reason FDA records is "Manufacturing error could result in electrolyte leakage from the product's battery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1681-2010
Status: Terminated
Initiated: 2010-01-19
Posted: 2010-05-26
Terminated: 2011-08-02
Recalling firm: Insound Medical, Inc.
Product: InSound Medical, Inc, Lyric in-canal hearing aid.
Product code: ESD Hearing Aid, Air-Conduction, Prescription
Reason for recall: Manufacturing error could result in electrolyte leakage from the product's battery.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: InSound sent to its consignees a "Dear Lyric Provider" letter of explanation on 2/1/2010.
Quantity in commerce: 2019 units
Distribution: Distribution only in US ( nationwide). No foreign consignees involved.
Product codes and lots: All devices manufactured between 12/10/2009 and 12/24/2009. Expiration dates 12/10/2010 through 12/24/2010.

Product code ESD

K081136Class ILyric Hearing AidInsound Medical, Inc. / cleared 2008-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)