Hearing Loss Trial, Recruiting NCT05318417 Sponsor: Cochlear Condition: Hearing Loss
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Hearing Loss Trial, Recruiting

NCT05318417
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:

  • Adults aged 18 or older (Group A), or children aged 5 to 17 years and 11 months (Group B)
  • The ear to be implanted has severe hearing loss in a specific range, with a pure-tone average above 80 dB HL at key frequencies, and very poor word recognition even with hearing aids (a score of 5% or less on a standard speech test)
  • The other ear has normal or near-normal hearing (average of 30 dB HL or better at key frequencies)
  • People who have previously tried a conventional treatment for single-sided hearing loss — such as a hearing aid, bone-conduction device, or CROS hearing aid — or who are willing to try one of these options for at least two weeks before joining
  • English is the person's primary spoken language
  • Willing and able to provide written consent to participate (for children, a parent or guardian would be involved in this process)

Who may not be able to join:

  • People whose inner ear (cochlea) has abnormalities such as bone growth, an unusual cochlear nerve, or other structural issues that may prevent the implant from being fully inserted
  • People who have already had a cochlear implant
  • People whose hearing loss originates from the nerve or brain, including a condition called auditory neuropathy
  • People who have had profound hearing loss in the ear to be implanted for more than 10 years (based on self-report)
  • People with an active or ongoing middle-ear infection, or a type of hearing loss caused by a physical blockage rather than nerve damage, in either ear
  • People whose overall health or psychological condition means surgery is not considered appropriate, as judged by the trial investigator
  • People whose expectations about what the implant can achieve are considered unrealistic, as judged by the trial investigator
  • People with signs of or concerns about cognitive or developmental difficulties
  • People who are unwilling or unable to follow the requirements of the trial, as judged by the trial investigator
  • Staff members at the trial site who are directly involved in this study, or their immediate family members (spouse, parent, child, or sibling)
  • Employees of Cochlear (the company running the trial) or employees of research organisations contracted to work on this trial
  • Women who are pregnant or breastfeeding
  • People who are currently taking part in, or have taken part in within the last 30 days, another clinical trial involving an experimental drug or medical device

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 28 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.

Contact this trial

Principal Investigator: Jillian Crosson, Cochlear

Phone: +612294286555

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Cochlear
Registry
ClinicalTrials.gov
Start date
19 August 2022
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.; Number of procedure and device related adverse events classified by type, frequency and severity.

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: 28 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