Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid (NCT04761926) | Clinical Trial Compass
CompletedNot Applicable
Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid
Denmark20 participantsStarted 2021-01-15
Plain-language summary
The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.
Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.
The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.
Who can participate
Age range
12 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
. Signed Informed Consent Form
. 12 years old and above
. Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study
. Fluent in local language, as judged by the investigator
Exclusion criteria
. Participation in another clinical investigation which might cause interference with study participation.
. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion
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
1
To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use.
Timeframe: The outcome measure was assessed during Study Visit 1 (Day 1).