FDA Medical Device Recalls (openFDA)
Sonitus Medical Inc.: SoundBite Hearing System; Microphone Tube Size 0. 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.
- Recall number
- Z-1179-2012
- Recalling firm
- Sonitus Medical Inc.
- Product
- SoundBite Hearing System; Microphone Tube Size 0. 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.
- Status
- Terminated
- Initiated
- 2012-02-02
- Posted
- 2012-03-07
- Terminated
- 2012-03-23
- Reason
- Sonitas received reports of stress cracking on the SoundBite Microphone Tube.
- 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
- 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.
- Lot, serial or model codes
- Model number P02011 - Right, Lot M1110 and M1112 and P020012 - Left, lot M1109, M1111 and M1113.
- 510(k) numbers
- ["K110831"]
- PMA numbers
- not on file
- Product code
- LXB
- Firm FEI
- 3009200826
- Firm city
- San Mateo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28