NCT04237207

Clinical Evaluation of a Cochlear Implant Sound Processor

Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Advanced Bionics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

Detailed description

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Conditions

• Hearing Loss
• Ear Diseases
• Hearing Disorders
• Otorhinolaryngologic Diseases

Interventions

Type	Name	Description
DEVICE	Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software	Control cochlear implant sound processor
DEVICE	301-M062 sound processor & software	New cochlear implant sound processor

Timeline

• Start date: 2019-12-17
• Primary completion: 2020-10-15
• Completion: 2020-10-15
• First posted: 2020-01-23
• Last updated: 2022-05-13
• Results posted: 2022-05-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study