Hearing Loss Trial, Recruiting NCT07130136 Sponsor: Cochlear Condition: Hearing Loss
Back to Hearing Loss

Hearing Loss Trial, Recruiting

NCT07130136
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
  • People who have had a Cochlear Baha BI300 implant fitted together with a Cochlear Baha BA300 Abutment (known as the Baha Connect System)
  • People who have a type of hearing loss — either mixed or conductive — in the ear where the Baha Connect System is fitted
  • People whose bone conduction hearing test results in the implanted ear fall within a specific range (a PTA4 score of 55 dB HL or better — confirm with trial site if unsure what this means for a specific case)
  • People who have been using the Baha Connect System for at least 6 months
  • People whom the trial doctor has assessed as being unhappy with their current Baha Connect System due to medical problems, such as repeated skin reactions around the device, and who are considered likely to benefit from switching to an Osia System
  • People who are fluent speakers in the language being used to test hearing and speech understanding during the trial
  • People who are willing and able to sign a written consent form
  • People who have medical records going back to when their Baha Connect System was implanted, and where the trial site is authorised to review those records

Who may not be able to join:

  • People who are deaf in one ear but have normal or near-normal hearing in the other ear (specifically, an air conduction PTA4 score of 20 dB HL or better in the good ear — confirm with trial site)
  • People who have an active, severe skin infection at the implant site at the time of their initial screening appointment
  • People who, in the trial doctor's judgement, are unable or unwilling to follow the requirements of the trial
  • People who work at the trial site and are directly involved in running this study, or their immediate family members (spouse, parent, child, or sibling)
  • People who are employees of Cochlear (the company sponsoring the trial), or who work for research organisations or contractors hired by Cochlear to run this study
  • People who are currently taking part in another clinical trial involving an experimental drug or device, or who have done so in the past 30 days (unless the other trial is also run by Cochlear and the trial doctor or Cochlear determines there is no conflict)

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 20 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: PRS Specialist, Cochlear Ltd

Phone: +61 2 9428 6555

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
1 July 2026
Est. completion
1 November 2028

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Change (within-subject) in speech reception threshold in noise measured at 65 dB SPL (pre-operative unaided and post-operative aided with the Osia System)

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: 20 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