Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
Key facts
- Who runs it
- Oticon Medical
- Where
- Dallas, Indianapolis, New York, Portland, Richmond, and Sarasota, United StatesSee the 6 sitesAlso in 2 other countries, 2 sites
- Trial code
- Status
- Completed
- People taking part
- 64 people enrolled
- Started
- 15 Jun 2020
- Ended
- 10 Dec 2024
- Type of study
- Observational
- Treatments tested
- Abbreviated Profile Hearing Aid Benefit (APHAB)
- Glasgow Benefit Inventory (GBI)
- Additional follow-up visit
- Record updated
- 27 January 2025
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
- Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
- Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected
- Skin thickness of 12mm or less at the implant site
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
Where in United States
Also in 2 other countries, 2 sites
- UT Southwestern Medical CenterDallas, United States
- Otolaryngology AssociatesIndianapolis, United States
- New York Eye and Ear InfirmaryNew York, United States
- Northwest Ear InstitutePortland, United States
- Virginia Commonwealth UniversityRichmond, United States
- Silverstein InstituteSarasota, United States
About the trial
What the trial wants to find out
This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. 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. The total number of participants included in the study will be 64.
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The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).
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 an additional follow-up visit after surgery.
Treatment: Abbreviated Profile Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), and Additional follow-up visit
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)
- Record updated
- 27 January 2025