PMA P090018S039

Device: Esteem
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S039
Product code: OAF
Decision date: 2020-02-24
Generic name: Implant, hearing, active, middle ear, totally implanted
Approval order statement: Approval of the following changes to the post-approval study (i.e., the New Enrollment 2 study, approved under P090018/S030) for your device: (a) use the evaluable bone conduction data at 1 month as a safety endpoint to measure cochlear stability collected from the 45 subjects used for the efficacy endpoints (SRT and WRS), and (b) supplement the AE safety endpoints (SAEs including facial paresis/paralysis at 1 month) with data from a retrospective review of charts from patients not participating in the post-approval study.

Current openFDA PMA Record#

Device: Esteem
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S039
Product code: OAF
Generic name: Implant, hearing, active, middle ear, totally implanted
Decision date: 2020-02-24
Decision code: APPR
Date received: 2019-09-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the following changes to the post-approval study (i.e., the New Enrollment 2 study, approved under P090018/S030) for your device: (a) use the evaluable bone conduction data at 1 month as a safety endpoint to measure cochlear stability collected from the 45 subjects used for the efficacy endpoints (SRT and WRS), and (b) supplement the AE safety endpoints (SAEs including facial paresis/paralysis at 1 month) with data from a retrospective review of charts from patients not participating in the post-approval study.