Ponto Implantation Using a Minimally Invasive Surgical Technique

NCT04606823 | Completed Results

• 1 other identifier: BC108
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 7

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Number of Implants With Reliable Anchorage for a Sound Processor

  The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin overgrowth and pain preventing use of the sound processor. 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.

  3 months after implant surgery

Secondary Outcomes (15)

• Number of Implants With Reliable Anchorage for a Sound Processor

  12 months after implant surgery

• Implant Survival

  12 months after implant surgery

• Implant Stability

  12 months after implant surgery

• Holgers Score Distribution

  9 days, 5 weeks, 3-, 6-, and 12 months after implant surgery, and unplanned visits

• Max Holgers Score

  12 months after implant surgery

Study Arms (1)

Single-arm

OTHER

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.

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

Interventions

Glasgow Benefit Inventory (GBI) OTHER

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

Single-arm

Additional follow-up visits after surgery OTHER

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

Single-arm

Minimally invasive surgery PROCEDURE

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

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (7)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Univerisity Medical Center Groningen

Groningen, Netherlands

Location

Radboud University Medical Center

Nijmegen, 6525EX, Netherlands

Location

Sahlgrenska University Hospital

Gothenburg, 413 46, Sweden

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2WB, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Teunissen EM, Aukema TW, Banga R, Eeg-Olofsson M, Hol MKS, Hougaard DD, Tysome JR, Johansson ML, Svensson S, Powell HRF. Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study. Otol Neurotol. 2024 Oct 1;45(9):1037-1044. doi: 10.1097/MAO.0000000000004315. Epub 2024 Aug 26.

  PMID: 39186326 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Oticon Medical

studyinfo@oticonmedical.com

+46 31 748 6100

Study Officials

• Harry Powell, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: November 4, 2020
• Primary Completion: August 9, 2022
• Study Completion: April 26, 2023
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Locations

GB (3); DK (1); NL (2); SE (1)