Device Recall SoundBite Microphone Tube

  • Model / Serial
    Model number P02019 - Right, lot M1102 and P020020 - Left, lot M1105.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sonitus Medical Inc., 1825 S Grant St Ste 350, San Mateo CA 94402-7033
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model number P02011 - Right, Lot M1110 and M1112 and P020012 - Left, lot M1109, M1111 and M1113.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Model number P02013 - Right, lot M1098, M1106 and P020014 - Left, lot M109, M1102 and M1107.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    SoundBite Hearing System; Microphone Tube Size 1. 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.
  • Manufacturer
  • Model / Serial
    Model number P02015 - Right, lot M1099 and P020016 - Left, lot M1096, M1103.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    SoundBite Hearing System; Microphone Tube Size 2. 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.
  • Manufacturer
  • Model / Serial
    Model number P02017 - Right,lot M1100 and P020018 - Left, lot M1104, M1097.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class III Recall - Nationwide Distribution, including the states of CA, AZ, PA, MI, UT, NC, NY, WI, TX, FL and DC.
  • Product Description
    SoundBite Hearing System; Microphone Tube Size 3. 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.
  • Manufacturer