CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
HiRes 90K Bionic Ear Systemdevice
Likely dose
HiRes 90K Bionic Ear System bilateral cochlear implantationAI-extracted
Key inclusion· 6
  • Age 18 years or older
  • Postlingual onset of hearing loss (hearing loss occurring after language development)
  • Severe or greater sensorineural hearing loss in both ears
  • Normal or patent cochlear anatomy in each ear
Key exclusion· 4
  • Previous cochlear implant experience
  • Prelingual onset of hearing loss
  • Hearing loss less severe than severe in either ear
  • Abnormal or non-patent cochlear anatomy in either ear

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00205881
NCT00205881Phase 4Completed

Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Advanced Bionics·interventional·Posted Sep 21, 2005·Updated Mar 1, 2012

In Brief

A Phase 4 clinical trial evaluating HiRes 90K Bionic Ear System for Hearing Loss. Completed, enrolled 32 participants across 9 sites.

Detailed Summary

Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartOct 1, 2004
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.8 years ago

Interventions

HiRes 90K Bionic Ear Systemdevice

Cochlear implant system