Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

NCT04310202 | Completed

• 1 other identifier: Doc-00066211
• Study Type: observational
• Target: 50
• Locations: 3 countries
• Sites: 6

Brief Summary

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). 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. A total of 50 patients will be included in the study. The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Implant/abutment complex capability to provide a reliable Anchorage for a 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

Secondary Outcomes (18)

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

  12 months after implant surgery

• Implant survival

  12 months after implant surgery

• Implant stability

  12 months after implant surgery

• Holgers score ratings

  12 months after implant surgery

• IPS (Inflammation, Pain, Skin height) scores

  12 months after implant surgery

Other Outcomes (1)

• Safety outcome

  12 months after surgery

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 additional follow-up visits after surgery.

Other: Abbreviated Profile of Hearing Aid Benefit (APHAB); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery

Interventions

Abbreviated Profile of 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 two 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 two occasions.

Single-arm

Additional follow-up visits after surgery OTHER

There are 1-2 additional follow-up visits 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
• Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines
• Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected

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 (6)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hospital Universitario de Donostia

San Sebastián, Gipuzkoa, 20014, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2WB, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

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 Officials

• Rupan Banga, MD, PhD

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: January 17, 2021
• Primary Completion: April 24, 2023
• Study Completion: December 20, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

DK (2); ES (2); GB (2)