Baha 5 SuperPower Earhook+ (Medium, Mocha) P771902

GUDID 09321502034517

Cochlear Bone Anchored Solutions AB

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502034517
• NIH Device Record Key: 43ee5c26-d914-4a11-8adb-a4fc879928a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha 5 SuperPower Earhook+ (Medium, Mocha)
• Version Model Number: P771902
• Catalog Number: P771902
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502034517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153245

FDA Product Code

• LXB: Hearing aid, bone conduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-27
• Device Publish Date: 2016-10-24

Devices Manufactured by Cochlear Bone Anchored Solutions AB

• 09321502020848 - Irrigation Tubing Set 3,8 m: 2024-12-12
• 09321502019651 - Baha: 2024-09-19 Abutment instrument set
• 09321502034654 - Baha: 2023-11-29 Baha 5 Power Battery door
• 09321502040174 - Baha: 2023-11-29 BP110 Power battery doors Apple Green
• 09321502040181 - Baha: 2023-11-29 BP110 Power battery doors Ocean Blue
• 09321502040198 - Baha: 2023-11-29 BP110 Power battery doors Iris Purple
• 09321502040204 - Baha: 2023-11-29 BP110 Power battery doors Ruby Red
• 09321502040259 - Baha: 2023-11-29 Inner Case BP110 (Spare part)