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

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

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).

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Abbreviated Profile Hearing Aid Benefit (APHAB); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visit

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 Patients who are withdrawn from the study prior to completion will not be replaced.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 Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3H 2R9
      • The Research Institute of the McGill University Health Centre
• Spain
  • Gipuzkoa
    • San Sebastián, Gipuzkoa, Spain, 20014
      • Hospital Universitario DE Donostia
• United States
  • Florida
    • Sarasota, Florida, United States, 34239
      • Silverstein Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Otolaryngology Associates
  • New York
    • New York, New York, United States, 10003
      • New York Eye and Ear Infirmary
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Ear Institute
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to participating clinics who meet clinical indications for surgical intervention with a bone anchored hearing system.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single-arm; 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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant/abutment complex capability to provide reliable anchorage for sound processor	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.	3 months after implant surgery (MIPS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant/abutment complex capability to provide reliable anchorage for sound processor	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.	12 months after implant surgery (MIPS)
Implant survival	Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place [Yes/No]	12 months after implant surgery (MIPS)
Implant stability	Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]	12 months after implant surgery (MIPS)
Holgers score ratings	Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator	12 months after implant surgery (MIPS)
IPS scores	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	12 months after implant surgery (MIPS)
Patient-perceived presence of pain around implant/abutment	Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject	12 months after implant surgery (MIPS)
Patient-perceived magnitude of pain around implant/abutment	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	12 months after implant surgery (MIPS)
Patient-perceived presence of numbness around implant/abutment	Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject	12 months after implant surgery (MIPS)
Patient-perceived magnitude of numbness around implant/abutment	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	12 months after implant surgery (MIPS)
Skin/soft tissue overgrowth	Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question	12 months after implant surgery (MIPS)
Duration of surgery	Length of surgery measured in minutes	At implant surgery (MIPS)
Wound dehiscence	Prevalence of wound dehiscence measured as millimeters of dehiscence	12 months after implant surgery (MIPS)
Wound healing time	Average healing time [days] from surgery when the wound is considered healed	12 months after implant surgery (MIPS)
Implant/abutment usage	Mean hours of use of a sound processor on the implant/abutment	12 months after implant surgery (MIPS)
Subjective benefit after MIPS surgery	Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome	At screening visit (visit before surgery)
Subjective benefit after MIPS surgery	Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a higher global score corresponds to a poorer outcome	6 months after implant surgery (MIPS)
Subjective benefit after MIPS surgery	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	3 months after implant surgery (MIPS)
Subjective benefit after MIPS surgery	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	12 months after implant surgery (MIPS)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Occurrence and severity of both related and unrelated adverse events after MIPS surgery	12 months after implant surgery (MIPS)

Collaborators and Investigators

• Sponsor: Oticon Medical

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: BC100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No