CompletedNot Applicable

Evaluation of the BHX Implant in Children with a BAHS

United Kingdom15 participantsStarted 2018-05-22

Plain-language summary

The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.

Who can participate

Age range

5 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
. Signed informed consent.
. Patients between 5 - 16 years of age.
. Patients eligible for one stage surgery.
. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion criteria

. Patients who cannot attend follow up visits.
. Patients with single side deafness (SSD).
. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
. Patients who receive other implant than the Ponto BHX.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Implant stability

Timeframe: 6 months post surgery

Trial details

NCT IDNCT03742089

SponsorOticon Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-14

View on ClinicalTrials.gov More Hearing Loss, Conductive trials