Hearing Loss Trial, Recruiting NCT06375278 Sponsor: Restorear Devices LLC Condition: Hearing Loss
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Hearing Loss Trial, Recruiting

NCT06375278
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 years or older who have been diagnosed with severe to profound hearing loss and are already planning to have cochlear implant surgery at the University of Miami.
  • People with profound sensorineural (nerve-related) hearing loss may be eligible for the safety portion of the trial (up to 6 participants).
  • People with some remaining hearing, as measured by a pre-surgery hearing test called an auditory brainstem response (ABR), may be eligible for the main efficacy portion of the trial (up to 48 participants).
  • The trial aims to enroll equal numbers of men and women, and participants may speak either English or Spanish.
  • The cochlear implant surgery, pre- and post-surgery care, and device setup are all considered standard medical care and are not experimental parts of the trial.
  • The trial accepts participants receiving cochlear implant devices from any of the three main manufacturers — Advanced Bionics, Cochlear Corporation, or Med-EL — where the device has been approved by the FDA for that person's level of hearing loss (confirm with trial site).
  • People receiving cochlear implant devices not listed in the trial description may also be considered eligible, as manufacturer criteria can change (confirm with trial site).

Who may not be able to join:

  • People under 18 years of age.
  • People who do not meet the specific hearing requirements set out for the trial.

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 27 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

Phone: 801-641-8180

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
Restorear Devices LLC
Registry
ClinicalTrials.gov
Start date
23 September 2024
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pure Tone Audiometry

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: 27 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