Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant

NARecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 6, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2028

Conditions
Sensori-Neural DeafnessSensorineural Hearing LossSensorineural Hearing Loss (Disorder)Sensorineural Hearing Loss, BilateralSensorineural Hearing Loss, ProfoundSensorineural Hearing Loss, Severe
Interventions
DEVICE

Acclaim Cochlear Implant

Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure).

Trial Locations (7)

29425

RECRUITING

MUSC Health, Charleston

32607

NOT_YET_RECRUITING

University of Florida Health, Gainesville

44195

NOT_YET_RECRUITING

Cleveland Clinic, Cleveland

55902

RECRUITING

Mayo Clinic, Rochester

73114

NOT_YET_RECRUITING

Hearts for Hearing, Oklahoma City

85718

RECRUITING

Center for Neurosciences Ear and Hearing Center, Tucson

90740

RECRUITING

Shohet Ear Associates, Seal Beach

Sponsors
All Listed Sponsors
lead

Envoy Medical Corporation

INDUSTRY