Hearing Loss Trial, Recruiting NCT04506853 Sponsor: Med-El Corporation Condition: Hearing Loss
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Hearing Loss Trial, Recruiting

NCT04506853
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 5 years old or older at the time of receiving the implant
  • You have severe to total hearing loss in one ear, with hearing test results showing a loss of 90 dB or greater in that ear
  • Your hearing loss in the ear to be implanted is caused by a problem with the inner ear (the nerve or sensory cells), rather than the outer or middle ear
  • Your other ear (the one not being implanted) has normal hearing or only mild to moderate hearing loss, with test results of 55 dB or less
  • You can correctly identify 5% or fewer words on a standard word recognition test in the ear to be implanted
  • You have previously tried a hearing device such as a CROS hearing aid, bone conduction device, or traditional hearing aid, as considered appropriate by the study team
  • You are fluent in English

Who may not be able to join:

  • Your severe hearing loss in the affected ear has lasted for 10 years or more
  • The hearing part of your inner ear (the cochlea) is absent or not working, or the hearing nerve is not functioning
  • You have a type of hearing loss that originates beyond the inner ear, in the hearing nerve or brain pathways (confirm with trial site)
  • You have significant structural problems with your inner ear, such as an abnormal shape or a buildup of bone within it
  • You currently have an infection in your outer or middle ear
  • There are concerns about your developmental or cognitive (thinking and learning) abilities
  • You have a health condition that would make surgery or general anesthesia unsafe for you

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Med-El Corporation
Registry
ClinicalTrials.gov
Start date
22 February 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov