Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
15 participants
OBSERVATIONAL
2018-05-22
2024-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
NCT03723161
Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
NCT04310202
Single-stage Surgery Using the BHX Implant
NCT04039802
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
NCT04006132
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
NCT04279236
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Bone Anchored Hearing Surgery using a BHX implant manufactured by Oticon Medical
Bone Anchored Hearing Surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bone Anchored Hearing Surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Signed informed consent.
3. Patients between 5 - 16 years of age.
4. Patients eligible for one stage surgery.
5. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.
Exclusion Criteria
2. Patients with single side deafness (SSD).
3. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
4. Patients who receive other implant than the Ponto BHX.
\-
5 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oticon Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The James Cook University Hospital
Middlesbrough, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C52
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.