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New sound processor boosts hearing in small trial
NCT ID NCT05628285
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new sound processor (Sentio 1) for people with conductive or mixed hearing loss who already have a bone-anchored implant. Eleven adults participated, and the main goal was to see how much their hearing improved with the device. The results showed measurable hearing gains, but the study was small and had no control group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sentio 1 sound processor (device)
- What this could lead to
- If successful, this could provide better hearing for people with conductive or mixed hearing loss who already have a bone-anchored implant.
- What could go wrong
- This was a very small study (11 people) with no comparison group, so results may not apply to everyone. It only tested short-term hearing improvement.
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
-
11 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Nov 2024
- 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: 1. Signed Informed Consent Form 2. Adult subjects (18 years or older) 3. Subjects implanted with an I1 implant 4. Fluent in Swedish Exclusion Criteria: 1. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion. 2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.
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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
-
Habilitation & Health, Hearing organization
Gothenburg, 41663, Sweden
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Other studies related to the condition(s) this trial covers.
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