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

A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Abbreviated Profile of Hearing Aid Benefit (APHAB); Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery

Detailed Description

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 BHX Implant system. 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): 50

Contacts and Locations

• Study Contact: Name: Sukhi Singh, PhD; Phone Number: 0046734219323; Email: suin@oticonmedical.com

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• Spain
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Gipuzkoa
    • San Sebastián, Gipuzkoa, Spain, 20014
      • Hospital Universitario de Donostia
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust

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
• 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

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 additional follow-up visits after surgery.

Other: Abbreviated Profile of 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 two 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 two occasions.; Other: Additional follow-up visits after surgery; There are 1-2 additional follow-up visits 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 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 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
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
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
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
IPS (Inflammation, Pain, Skin height) 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
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
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
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
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
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
Duration of surgery	Length of surgery measured in minutes	At implant surgery
Wound dehiscence	Prevalence of wound dehiscence measured as millimeters of dehiscence	12 months after implant surgery
Wound healing time	Average healing time [days] from surgery when the wound is considered healed	12 months after implant surgery
Implant/abutment usage	Mean hours of use of a sound processor on the implant/abutment	12 months after implant surgery
Subjective benefit after implant 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 implant surgery	Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome	6 months after implant surgery
Subjective benefit after implant 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
Subjective benefit after implant 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	Occurrence and severity of adverse events related to the investigational device and corresponding procedures	12 months after surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Rupan Banga, MD, PhD, University Hospital Birmingham NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2021
• Primary Completion (Actual): April 24, 2023
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Doc-00066211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No