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Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)

NCT04279236 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2025-01-27

No results posted yet for this study

Summary

This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. 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. The total number of participants included in the study will be 64.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).

Conditions

Interventions

OTHER

Abbreviated Profile 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 2 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 2 occasions.

OTHER

Additional follow-up visit

There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2024-05-20
Completion
2024-12-10

Countries

  • United States
  • Canada
  • Spain

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 NCT04279236 on ClinicalTrials.gov