Ponto Implantation Using a Minimally Invasive Surgical Technique

Oticon Medical

Status: Completed

Conditions: Hearing Loss

Treatments: Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery; Procedure: Minimally invasive surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04606823

BC108

Details and patient eligibility

About

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.

Full description

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery.

Enrollment: 52 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
• Signed informed consent
• Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
• Skin thickness of 12 mm or less at the implant site

Exclusion criteria

• Patient undergoing re-implantation
• Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
• Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
• Known medical condition that contraindicate surgery as judged by the investigator
• Known and/or planned pregnancy at time of surgery
• Any other known condition that the investigator determines could interfere with compliance or investigation assessments
• Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Single-arm

Other group

Description:

In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.

Treatment:

Procedure: Minimally invasive surgery

Other: Additional follow-up visits after surgery

Other: Glasgow Benefit Inventory (GBI)