AudioKey 1.0 and AudioLink
FDA premarket approval P000025/S109 · decided 2019-05-08
Approval details
- PMA number
- P000025
- Supplement
- S109
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AudioKey 1.0 and AudioLink
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2019-01-31
- Decision date
- 2019-05-08
- Days to decision
- 97 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval for AudioKey 1.0 and AudioLink. AudioKey 1.0 is an optional mobile medical application (App) that runs on smartphones with either the iOS or Android operating systems. When used with a compatible audio processor, AudioKey 1.0 (with smartphone) permits the same remote-control functions as the existing approved FineTuner remote control. AudioLink is an optional wireless hardware accessory that serves as an interface between an existing compatible MED-EL audio processor and a smartphone in
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