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Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

NCT02811549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-21

Study results available
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Summary

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

Conditions

  • Hearing Loss
  • Ear Diseases
  • Hearing Disorders
  • Otorhinolaryngologic Diseases
  • Asymmetrical Hearing Loss
  • Single-Sided Deafness

Interventions

DEVICE

HiResolution Bionic Cochlear Implant

HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.

Sponsors & Collaborators

  • Advanced Bionics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-07
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02811549 on ClinicalTrials.gov