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Clinical Evaluation of a Cochlear Implant Sound Processor

NCT04237207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-05-13

Study results available
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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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Advanced Bionics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-17
Primary Completion
2020-10-15
Completion
2020-10-15
FDA Device
Yes

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 NCT04237207 on ClinicalTrials.gov