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Hearing implants without the OR: a safer, simpler approach?

NCT ID NCT06930781

Disease control Sponsor: Oticon Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study looks at what happens when people get a bone-anchored hearing device (Ponto) implanted outside a main operating room—for example, in a clinic procedure room. The goal is to track complication rates and see if this less intensive setting is safe and effective. Researchers will follow 270 adults who had the procedure from 2019 onward, collecting data on any problems during surgery and how the procedure room was set up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ponto bone-anchored hearing device
What this could lead to
If successful, this could show that implanting hearing devices outside the main operating room is safe, potentially making the procedure more accessible and convenient.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients or settings.

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.

Participants

About 270 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Apr 2027

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.

Who is studied

Bone-conduction hearing device users

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: * Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards * Signed informed consent (applicable for subjects answering questionnaires) Exclusion Criteria: * No exclusion criteria have been set for this observational investigation

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone anchored hearing AIDS Hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clinical Hospital from the Ribeirão Preto Medical School

    ACTIVE_NOT_RECRUITING

    São Paulo, São Paulo, 3900, Brazil

  • Hospital Virgen de las Nieves

    ACTIVE_NOT_RECRUITING

    Granada, Andalusia, 18014, Spain

  • Northern California Veterans Affairs Healthcare System

    RECRUITING

    Sacramento, California, 95655, United States

  • Queen Elizabeth II Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Skåne University Hospital

    ACTIVE_NOT_RECRUITING

    Lund, Skåne County, 22185, Sweden

  • Sunderby Sjukhus

    ACTIVE_NOT_RECRUITING

    Luleå, Norrbotten County, 971 80, Sweden

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