Evaluation of the BHX implant in children with a BAHS
Research type
Research Study
Full title
Evaluation of implant stability and audiological benefit of Oticon Medical BHX implant in children undergoing surgery for a percutaneous bone anchored hearing system (BAHS)
IRAS ID
211928
Contact name
Anirvan Banerjee
Contact email
Sponsor organisation
Oticon Medical AB
Duration of Study in the UK
2 years, 1 months, 0 days
Research summary
Objective(s): The primary objective is to collect data to evaluate Ponto BHX implant stability in a pediatric population undergoing BAHS. Our secondary objective is to compare outcomes in audiology, quality of life, and sound processor usage pre- and post-surgery.
Methodology: Prospective study of surgical, implant, audiological and patient data.
Product: Ponto BHX implant with abutments and Ponto sound processor developed by Oticon Medical AB (Gothenburg, Sweden). All products are CE marked.
Inclusion Criteria
1. Patients who have decided to undergo a Bone Anchored Hearing Surgery.
2. Patients between 5 - 16 years of age.
3. Patients eligible for one stage surgery.
4. Patients who have been using Ponto sound processor on a softband for at least 2 weeks.
Exclusion Criteria
1. Patients who cannot attend follow up visits.
2. Patients with single sided deafness (SSD).
3. In surgeons’ opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
4. Patients who use other implant than Ponto BHX.
Early Termination
1. Patients who do not want to continue to participate.
2. Children with thin bone unable to use the 3 mm fixture.
3. Patients who have to undergo two-stage surgery.
4. Patients who could not attend any follow up visits before the primary end-point (6months).
5. Patients who switch to other non-Ponto brand of sound processor.
6. If the physician assesses that the patient is not fit for trial participation at any stage.Intervention(s) : Implantation of a bone anchored hearing system and the fitting of a sound processor 3-4 weeks after implant surgery.
Duration of study period: 24 months after implant surgery.
Criteria for safety: No complications other than those that might occur when rehabilitating patients with a bone anchored hearing aid during standard care is anticipated. The study will be monitored by the sponsor for Severe Adverse Events and Adverse Events. Appropriate action will be taken in such cases keeping patient safety in mind.
Statistical methods: Each participant acts as their own control, we will use descriptive statistics to analyse data.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0275
Date of REC Opinion
24 Oct 2017
REC opinion
Unfavourable Opinion