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Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

NCT04310202 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-08-29

No results posted yet for this study

Summary

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

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

Conditions

Interventions

OTHER

Abbreviated Profile of Hearing Aid Benefit (APHAB)

An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions.

OTHER

Glasgow Benefit Inventory (GBI)

An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions.

OTHER

Additional follow-up visits after surgery

There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Rupan Banga, MD, PhD · University Hospital Birmingham NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-17
Primary Completion
2023-04-24
Completion
2023-12-20

Countries

  • Denmark
  • Spain
  • United Kingdom

Study Locations

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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 NCT04310202 on ClinicalTrials.gov