New hearing implant could offer better sound for bone conduction users
NCT ID NCT07130136
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 9 times
Summary
This study will test a newer bone conduction implant, the Osia system, against an older one, the Baha Connect system, in 20 adults with mixed or conductive hearing loss. Participants already have a Baha implant and will switch to the Osia system. Researchers will measure speech understanding in noise and track any side effects to see if the Osia system is safer and works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cochlear Osia System (bone conduction implant device)
- What this could lead to
- If successful, this could show that the Osia system is a safe and better option for people with hearing loss who already have a Baha implant.
- What could go wrong
- This is a small, early post-market study with only 20 participants, so results may not apply to everyone. There is also a risk of device-related side effects or no clear benefit over the existing system.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 18 years of age or older * Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect) * Mixed or conductive hearing loss in the ear implanted with the Baha Connect System * Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System * Experience of at least 6 months with the Baha Connect System * Candidate is judged by the investigator to be dissatisfied with their current Baha Connect System due to medical issues, e.g., recurrent adverse skin reactions, and is considered likely to benefit from transitioning to an Osia System * Candidate is a fluent speaker in the language used to assess speech perception performance * Candidate is willing and able to provide written informed consent * Candidate has a retrospective medical record from the time of implantation with the Baha Connect System which the investigational site is authorized to review Exclusion Criteria: * Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear) * Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling * Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation * Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by the investigator or Sponsor to not impact this investigation)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone conduction are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Nottingham Auditory Implant Programme
NOT_YET_RECRUITINGNottingham, NG1 5DU, United Kingdom
-
Royal National Ear, Nose and Throat and Eastman Dental Hospitals
RECRUITINGLondon, WC1E 6DG, United Kingdom
-
Sheffield Teaching Hospitals
RECRUITINGSheffield, S10 2JF, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new bone conduction implant restore hearing for the long haul?
- Which hearing test works best for preschoolers? major study aims to find out
- New sound processor promises sharper hearing for implant users
- Glasses that help you hear: new study tests smart spectacles for hearing loss
- New hearing implant shows promise for kids under five
- Hearing aid study explores link between better hearing and brain health