Wider hearing implant holds up after a decade, study finds
NCT ID NCT05058066
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study followed 51 adults who received a wider bone-anchored hearing implant (BIA300) to see how well it stayed in place and worked after 10 years. Researchers measured implant stability and checked for any skin or tissue problems. The goal was to see if the wider design is a better long-term option than older, narrower implants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Baha® BIA300 Implant (wide-diameter titanium implant with abutment)
- What this could lead to
- If successful, this could confirm that the wider implant is a reliable long-term option for people with hearing loss who need a bone-anchored device.
- What could go wrong
- This is a small, single-center follow-up study with only 51 participants, so results may not apply to everyone. It also only measures outcomes at one 10-year visit, not continuously.
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
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51 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Sep 2020
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * To be included in the original trials, patients had to be at least 18 years old. Exclusion Criteria: * Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.
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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.
Contacts and locations
Locations
-
Radboudumc
Nijmegen, Gelderland, 6525EX, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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