Cochlear™ Baha® 6 Max Demo Sound Processor, Black P1668395

GUDID 09321502052078

Cochlear Bone Anchored Solutions AB

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502052078
• NIH Device Record Key: 97217629-1516-49b3-b1db-1aff5644cc2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Baha® 6 Max Demo Sound Processor, Black
• Version Model Number: P1668395
• Catalog Number: P1668395
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502052078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202048

FDA Product Code

• LXB: Hearing aid, bone conduction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

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• 09321502074711 - Baha 7 Sound Processor, Black: 2025-06-13
• 09321502074728 - Baha 7 Sound Processor, Silver: 2025-06-13
• 09321502074735 - Baha 7 Sound Processor, Brown: 2025-06-13
• 09321502074742 - Baha 7 Sound Processor, Copper: 2025-06-13
• 09321502074759 - Baha 7 Sound Processor, Mint: 2025-06-13