Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)
Key facts
- Who runs it
- Oticon Medical
- Where
- Denmark, Spain, and United Kingdom6 sites in 3 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 17 Jan 2021
- Ended
- 20 Dec 2023
- Type of study
- Observational
- Treatments tested
- Abbreviated Profile of Hearing Aid Benefit (APHAB)
- Glasgow Benefit Inventory (GBI)
- Additional follow-up visits after surgery
- Record updated
- 29 August 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 18 years of age or older
- Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected
Who cannot take part
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
- Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
- Any other known condition that the investigator determines could interfere with compliance or study assessments
- Patients undergoing re-implantation
- Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
This trial has no sites in United States.
It has sites in 3 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.
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The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.
The group in the trial
- Single-arm
In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and additional follow-up visits after surgery.
Treatment: Abbreviated Profile of Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), and Additional follow-up visits after surgery
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
- Record updated
- 29 August 2024