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

Completed

• Conditions: Hearing Loss
• Interventions: Other: Abbreviated Profile Hearing Aid Benefit (APHAB); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visit

• Registration Number: NCT04279236
• Lead Sponsor: Oticon Medical

Brief 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).

Detailed 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 Patients who are withdrawn from the study prior to completion will not be replaced.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.

Study Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-06-15
• Primary Completion: 2024-05-20
• Study Completion: 2024-12-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 18 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-arm	Abbreviated Profile Hearing Aid Benefit (APHAB)	In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery.
Single-arm	Additional follow-up visit	In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery.
Single-arm	Glasgow Benefit Inventory (GBI)	In this single-arm study, the only interventions compared to routine clinical practice are the completion of two patient questionnaires (APHAB and GBI) and an additional follow-up visit after surgery.

Primary Outcome Measures

Name	Time	Method
Implant/abutment complex capability to provide reliable anchorage for sound processor	3 months after implant surgery (MIPS)	The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth 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 or skin over-growth and pain preventing usage of the sound processor.

Secondary Outcome Measures

Name	Time	Method
IPS scores	12 months after implant surgery (MIPS)	Distribution of IPS (Inflammation \[total score 0-4\], Pain \[score 0-2\], Skin height \[score 0-2\]) scores assigned by investigator. The IPS score is presented as \[Ix Px Sx\] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome
Patient-perceived magnitude of pain around implant/abutment	12 months after implant surgery (MIPS)	Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome
Subjective benefit after MIPS surgery	12 months after implant surgery (MIPS)	Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where \[-100\] means maximum adverse effect, \[0\] means no effect, and \[+100\] means maximum positive effect
Implant/abutment complex capability to provide reliable anchorage for sound processor	12 months after implant surgery (MIPS)	The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth 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 or skin over-growth and pain preventing usage of the sound processor.
Wound dehiscence	12 months after implant surgery (MIPS)	Prevalence of wound dehiscence measured as millimeters of dehiscence
Wound healing time	12 months after implant surgery (MIPS)	Average healing time \[days\] from surgery when the wound is considered healed
Implant stability	12 months after implant surgery (MIPS)	Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable \[Yes/No\]
Implant survival	12 months after implant surgery (MIPS)	Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place \[Yes/No\]
Holgers score ratings	12 months after implant surgery (MIPS)	Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator
Duration of surgery	At implant surgery (MIPS)	Length of surgery measured in minutes
Patient-perceived presence of pain around implant/abutment	12 months after implant surgery (MIPS)	Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject
Patient-perceived presence of numbness around implant/abutment	12 months after implant surgery (MIPS)	Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject
Patient-perceived magnitude of numbness around implant/abutment	12 months after implant surgery (MIPS)	Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome
Skin/soft tissue overgrowth	12 months after implant surgery (MIPS)	Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question
Implant/abutment usage	12 months after implant surgery (MIPS)	Mean hours of use of a sound processor on the implant/abutment

Trial Locations

Locations (8)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

The Research Institute of the McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Hospital Universitario de Donostia; 🇪🇸 San Sebastián, Gipuzkoa, Spain

Northwest Ear Institute; 🇺🇸 Portland, Oregon, United States

Silverstein Institute; 🇺🇸 Sarasota, Florida, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Otolaryngology Associates; 🇺🇸 Indianapolis, Indiana, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States