New minimally invasive ear implant surgery shows promise for hearing loss
NCT ID NCT04606823
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new, less invasive surgical method for placing a bone-anchored hearing device (Ponto implant) in 52 adults with hearing loss. The goal was to see if the implant stayed securely in place without causing skin problems or pain. The approach aims to make the procedure easier and safer for patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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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52 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Apr 2023
- Lead sponsor
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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
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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: * 18 years of age or older * Patient indicated for surgical intervention with a bone anchored hearing system * Signed informed consent * Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected * Skin thickness of 12 mm or less at the implant site Exclusion Criteria: * Patient undergoing re-implantation * Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales * Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest) * Known medical condition that contraindicate surgery as judged by the investigator * Known and/or planned pregnancy at time of surgery * Any other known condition that the investigator determines could interfere with compliance or investigation assessments * Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
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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
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Aalborg University Hospital
Aalborg, 9000, Denmark
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Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
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Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
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Radboud University Medical Center
Nijmegen, 6525EX, Netherlands
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Sahlgrenska University Hospital
Gothenburg, 413 46, Sweden
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Univerisity Medical Center Groningen
Groningen, Netherlands
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB, United Kingdom
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Other studies related to the condition(s) this trial covers.
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