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, 11 months, 29 days
Research summary
Objective(s): The primary objective of this study is to evaluate Ponto BHX implant in a pediatric population when employing an early fitting protocol. Our secondary objective is to evaluate the quality of life and usage post operatively (abutment fitting) compared to pre operative softband condition.
Methodology: Prospective study of surgical, implant, audiological and patient data.
Product: Ponto BHX implant with abutments developed by Oticon Medical AB.
Inclusion criteria:
• Patients eligible for treatment with a bone anchored hearing aid.
• Patients between 5 - 16 years of age.
• Patients eligible for one stage surgery.
• Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.Exclusion criteria:
• Patients who are deemed unsuitable for a bone anchored hearing implant system by the attending otolaryngologist/otologist.
• Patients who cannot attend follow up visits.
• Patients who do not want to continue to participate.
• Patients who have to undergo two-stage surgery.
• Patients with single side deafness (SSD).
• In surgeons opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
• Patients who pick another processor, any non- Ponto processor.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.
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
16/NE/0293
Date of REC Opinion
20 Sep 2016
REC opinion
Unfavourable Opinion