PMA P000025S109

Device: AudioKey 1.0 and AudioLink
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S109
Product code: MCM
Decision date: 2019-05-08
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order 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 installed with AudioKey 1.0.

Current openFDA PMA Record#

Device: AudioKey 1.0 and AudioLink
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S109
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2019-05-08
Decision code: APPR
Date received: 2019-01-31
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 installed with AudioKey 1.0.