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New minimally invasive ear implant surgery shows promise for hearing loss

NCT ID NCT04606823

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

52 people

The number who actually took part.

Started

Nov 2020

Finished

Apr 2023

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

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

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH, United Kingdom

  • Radboud University Medical Center

    Nijmegen, 6525EX, Netherlands

  • Sahlgrenska University Hospital

    Gothenburg, 413 46, Sweden

  • Univerisity Medical Center Groningen

    Groningen, Netherlands

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2WB, United Kingdom

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