Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

Oticon Medical

Status: Completed

Conditions: Hearing Loss

Treatments: Other: Abbreviated Profile of Hearing Aid Benefit (APHAB); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT04310202

Doc-00066211

Details and patient eligibility

About

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.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

Full description

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.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. 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: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

50 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 additional follow-up visits after surgery.

Treatment:

Other: Additional follow-up visits after surgery

Other: Glasgow Benefit Inventory (GBI)

Other: Abbreviated Profile of Hearing Aid Benefit (APHAB)