Hearing Loss Clinical Trial
Official title:
A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System
Verified date | August 2023 |
Source | Oticon Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Oticon Medical |
Denmark, Spain, United Kingdom,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04696835 -
fNIRS in Pediatric Hearing Aids
|
N/A | |
Completed |
NCT03662256 -
Reducing Childhood Hearing Loss in Rural Alaska Through a Preschool Screening and Referral Process Using Mobile Health and Telemedicine
|
N/A | |
Completed |
NCT04602780 -
Evaluating the Revised WORQ in CI Users
|
||
Completed |
NCT03723161 -
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
|
||
Completed |
NCT05086809 -
Investigation of an Updated Bone-anchored Sound Processor
|
N/A | |
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Completed |
NCT03428841 -
Audiovisual Assessment After Dural Puncture During Epidural Placement in Obstetric Patients
|
N/A | |
Completed |
NCT04559282 -
Home Test of New Sound Processor
|
N/A | |
Enrolling by invitation |
NCT03345654 -
Individually-guided Hearing Aid Fitting
|
||
Completed |
NCT06016335 -
MRI-based Synthetic CT Images of the Head and Neck
|
N/A | |
Completed |
NCT05165121 -
Comparison of Hearing Aid Fitting Outcomes Between Self-fit and Professional Fit for MDHearing Smart Hearing Aids
|
N/A | |
Recruiting |
NCT05533840 -
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
|
||
Terminated |
NCT02294812 -
Effects of Cognitive Training on Speech Perception
|
N/A | |
Completed |
NCT04622059 -
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
|
N/A | |
Recruiting |
NCT02558478 -
Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing
|
N/A | |
Withdrawn |
NCT02740322 -
Validating the Hum Test
|
N/A | |
Completed |
NCT01963104 -
Community-Based Kiosks for Hearing Screening and Education
|
N/A | |
Completed |
NCT01892007 -
Evaluation of Cogmed Working Memory Training for Adult Hearing Aid Users
|
N/A | |
Completed |
NCT01857661 -
The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
|
N/A | |
Withdrawn |
NCT01223638 -
The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism
|
N/A |