A Prospective Multi-Center Study on the Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (MIPS)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    64
  • sponsor
    Oticon Medical
Updated on 24 October 2022
hard of hearing
audiogram

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).

Description

This prospective, multi-centre 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. Patients who are withdrawn from the study prior to completion will not be replaced.

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). 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 sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Details
Condition Hearing Loss
Treatment Abbreviated Profile Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), Additional follow-up visit
Clinical Study IdentifierNCT04279236
SponsorOticon Medical
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older
Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected
Skin thickness of 12mm or less at the implant site

Exclusion Criteria

Patients undergoing re-implantation
Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator
Any other known condition that the investigator determines could interfere with compliance or study assessments
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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