Ponto implantation using a minimally invasive surgical technique v.2
Research type
Research Study
Full title
Evaluation of clinical performance of Ponto implantation using a minimally invasive surgical technique – a prospective multicentre study
IRAS ID
283503
Contact name
Harry Powell
Contact email
Sponsor organisation
Oticon Medical AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Research Summary:
This prospective, multi-centre study funded by Oticon Medical AB will be conducted at seven univeristy hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In the UK, the study will be performed at three sites (London, Cambridge and Birmingham). 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. Approximately 25 patients will be included in the UK and the total number of patients in the study will be 50.
The purpose of this study is to investigate the rate of successful BAHS use after implantation of a Ponto implant using a minimally invasive surgical technique (MONO surgical procedure). 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 vibrations transmitted directly to the inner ear via the bone. The primary objective is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for the sound processor 3 months after the MONO surgical procedure. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or pain preventing usage of the sound processor.
The study includes seven visits; one before surgery, surgery visit, and five follow-up visits (last visit 12 months after surgery). At the follow-up visits, the implant stability will be assessed, the skin around the implant will be examined and the patient will be asked about pain and numbness around the implant. In addition, complications and adverse events will be collected. Subjective evaluation of quality of life will be performed via a validated questionnaire (GBI). This is a post-market study and all products used are CE-marked.
Summary of Results:
Percutaneous bone-anchored hearing systems (BAHS) aims to improve hearing and have been used for more than 40 years. BAHS treatment involves having a titanium implant inserted in the skull behind the ear. The implant is fixed to an abutment (a connecting part), which sticks out through the skin to enable attachment of an external sound processor. In this study, a simplified one-stage surgical drilling procedure, the so-called MONO procedure, was investigated. The study was carried out from 2020 to 2023 by Oticon Medical AB, manufacturer of the devices used, in collaboration with treating doctors and healthcare staff at seven university hospitals in Europe.In total, 51 participants throughout Europe (25 in the UK) were included in the study and have helped to establish that the MONO procedure is safe and efficient to use in BAHS surgeries. All study participants were followed for one year after surgery. During this time, we collected data on possible complications, use of the sound processor and if the participants have benefitted from their hearing device.
The results are encouraging, and the MONO procedure shortens the surgery time without adding risks to the BAHS treatment. The study showed there were only a few and non-severe complications overall. Skin reactions around the abutment are a common complication after BAHS treatment, but in this study few participants had skin issues that needed treatment (so-called adverse skin reactions). Other complications seen were pain, numbness, bleeding and swelling, which are typical complications that may occur after BAHS treatment. Approximately half of the study participants experienced pain around the abutment on at least one occasion, but pain was transient in most cases. For three participants, consistent pain led to a wish to remove the implant. This request was also motivated by comorbidities or limited perceived benefit of the hearing device. One year after implantation 92% of implants were in place and stable. Four patients lost their implant – two due to accidents involving a bang to their head. Two of these participants have later received new implants outside of the study.
The majority of study participants experienced benefits of the treatment and reported to use their sound processor every day, all day. BAHS treatment also had a positive impact on reported quality of life with 96% experiencing an improvement. Overall, the study showed that the new surgical technique is safe and efficient, and that most participants are happy with their device.
REC name
South West - Frenchay Research Ethics Committee
REC reference
20/SW/0112
Date of REC Opinion
20 Oct 2020
REC opinion
Further Information Favourable Opinion