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

NCT04279236 | Completed

• 1 other identifier: BC100
• Study Type: observational
• Target: 64
• Locations: 3 countries
• Sites: 8

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).

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Implant/abutment complex capability to provide reliable anchorage for sound processor

  12 months after implant surgery (MIPS)

• Implant survival

  12 months after implant surgery (MIPS)

• Implant stability

  12 months after implant surgery (MIPS)

• Holgers score ratings

  12 months after implant surgery (MIPS)

• IPS scores

  12 months after implant surgery (MIPS)

Other Outcomes (1)

• Safety outcome

  12 months after implant surgery (MIPS)

Study Arms (1)

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); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visit

Interventions

Abbreviated Profile Hearing Aid Benefit (APHAB) OTHER

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.

Single-arm

Glasgow Benefit Inventory (GBI) OTHER

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.

Single-arm

Additional follow-up visit OTHER

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

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (8)

Silverstein Institute

Sarasota, Florida, 34239, United States

Location

Otolaryngology Associates

Indianapolis, Indiana, 46237, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Northwest Ear Institute

Portland, Oregon, 97210, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

Location

Hospital Universitario de Donostia

San Sebastián, Gipuzkoa, 20014, Spain

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 21, 2020
• Study Start: June 15, 2020
• Primary Completion: May 20, 2024
• Study Completion: December 10, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

ES (1); US (6); CA (1)