Ponto Implantation Using a Minimally Invasive Surgical Technique

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2023-04-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single-arm

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.

Group Type OTHER

Minimally invasive surgery

Intervention Type PROCEDURE

The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.

Glasgow Benefit Inventory (GBI)

Intervention Type OTHER

A quality of life-questionnaire is to be completed by the subjects at one occasion.

Additional follow-up visits after surgery

Intervention Type OTHER

There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).

Interventions

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Minimally invasive surgery

The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.

Intervention Type PROCEDURE

Glasgow Benefit Inventory (GBI)

A quality of life-questionnaire is to be completed by the subjects at one occasion.

Intervention Type OTHER

Additional follow-up visits after surgery

There are 1-3 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No