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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04310202
Other study ID # Doc-00066211
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 17, 2021
Est. completion date January 31, 2024

Study information

Verified date August 2023
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date January 31, 2024
Est. primary completion date April 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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).

Locations

Country Name City State
Denmark Aalborg University Hospital Aalborg
Denmark Rigshospitalet Copenhagen
Spain Hospital Universitario de Donostia San Sebastián Gipuzkoa
Spain Hospital Clinico Universitario de Valencia Valencia
United Kingdom University Hospitals Birmingham NHS Foundation Trust Birmingham
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Oticon Medical

Countries where clinical trial is conducted

Denmark,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety outcome Occurrence and severity of adverse events related to the investigational device and corresponding procedures 12 months after surgery
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Duration of surgery Length of surgery measured in minutes At implant surgery
Secondary Wound dehiscence Prevalence of wound dehiscence measured as millimeters of dehiscence 12 months after implant surgery
Secondary Wound healing time Average healing time [days] from surgery when the wound is considered healed 12 months after implant surgery
Secondary Implant/abutment usage Mean hours of use of a sound processor on the implant/abutment 12 months after implant surgery
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
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