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Ponto Implantation Using a Minimally Invasive Surgical Technique

NCT04606823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-01-29

Study results available
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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

Interventions

PROCEDURE

Minimally invasive surgery

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

OTHER

Glasgow Benefit Inventory (GBI)

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

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).

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Harry Powell, MD · Guy's and St Thomas' NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2022-08-09
Completion
2023-04-26

Countries

  • Denmark
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04606823 on ClinicalTrials.gov