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
239239
Contact name
Aniravan Banerjee
Contact email
Sponsor organisation
Oticon Medical AB
Duration of Study in the UK
3 years, 2 months, 15 days
Research summary
C52 Study: Evaluation of the BHX Implant in Children with a BAHS
Bone anchored hearing system (BAHS) are used for hearing rehabilitation for various hearing problems such as conductive hearing losses, mixed hearing losses and single sided deafness in the UK both in adults and children. A BAHS consist of a titanium implant fixed to the mastoid bone in the skull, a skin-penetrating abutment and a sound processor attached to the abutment. The sound processor receives the sound and converts the sound into vibrations that are transmitted through the the implant system to the skull thus reaching the cochlea to restore hearing.
This trial involves the Ponto BHX implant, a CE marked product launched in market in 2015.The Ponto BHX implant is used world-wide for BAHS surgery in adults and in children. However, there is a lack of data collected in a proactive manner over long term in a clinical setting after the BHX implant has been used in children. Such data is of importance to monitor the product in a clinical setting and for further innovation and treatment improvement. The aim is to collect this data by following pediatric patients in a clinical setting treated following clinical praxis at the James Cook University Hospital.
Pediatric patients (5-16 years) whose parents/guardians have already decided to go through a BAHS surgery will be invited to participate. These patients will be followed in the clinical setting for 24 months after surgery without making any significant changes to the hospitals pre-existing patient surgery and follow-up procedures. The study sponsor's have only added an extra visit which will facilitate close monitoring of the patient's progress.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0149
Date of REC Opinion
22 May 2018
REC opinion
Favourable Opinion