Z-1183-2012

SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or...

Name: Z-1183-2012 SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or...
Creator: Sonitus Medical Inc.
Published: 2012-02-02
License: https://open.fda.gov/license/

Sonitus Medical, Inc. / initiated 2012-02-02 / Terminated / root cause: manufacturing process

FDA source

Sonitus Medical Inc. began a recall of SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and... on 2012-02-02. The reason FDA records is "Sonitas received reports of stress cracking on the SoundBite Microphone Tube". 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-1183-2012
Status: Terminated
Initiated: 2012-02-02
Posted: 2012-03-07
Terminated: 2012-03-23
Recalling firm: Sonitus Medical, Inc.
Product: SoundBite Hearing System; Microphone Tube Size 4. For use in patients with moderately severe, severe or profound sensorineural hearing loss in one ear and normal hearing in the other or patients with conductive hearing loss where the pure tone average bond-conduction hearing threshold is better than or equal to 25 dB HL. Sonitus Medical, San Mateo, CA.
Product code: LXB Hearing Aid, Bone Conduction
Reason for recall: Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Letters were sent to all direct SoundBite customers on February 9, 2012 via certified mail. Customers were asked to remove the old microphone tubes and replace with the new enclosed microphone tubes. Return mail instructions were provided for the old microphone tubes. Customer questions were directed to 650-251-4185.
Quantity in commerce: 676 microphones, all sizes.
Distribution: Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
Product codes and lots: Model number P02019 - Right, lot M1102 and P020020 - Left, lot M1105.

Product code LXB

K110831Class IISoundbite Hearing System by Sonitus MedicalSonitus Medical, Inc. / cleared 2011-06-21

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)