Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)

Oticon Medical

Status: Completed

Conditions: Hearing Loss

Treatments: Other: Additional follow-up visit; Other: Glasgow Benefit Inventory (GBI); Other: Abbreviated Profile Hearing Aid Benefit (APHAB)

Study type: Observational

Funder types: Industry

Identifiers

NCT04279236

BC100

Details and patient eligibility

About

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.

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).

Full description

This prospective, multi-centre 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. Patients who are withdrawn from the study prior to completion will not be replaced.

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 implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients undergoing re-implantation
• Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
• 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.

Trial design

64 participants in 1 patient group

Single-arm

Description:

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:

Other: Abbreviated Profile Hearing Aid Benefit (APHAB)

Other: Glasgow Benefit Inventory (GBI)

Other: Additional follow-up visit