10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant

Status Completed

Clinical Trial Summary

A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.

Clinical Trial Description

This study is a continuation of two previous conducted trials: 1. Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant: 1. CAG5173: 6-month(1) and 3-year(2) data. 2. CBAS5562: 5-year data(3). 2. 3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data. In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation. Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period. ;

Study Design

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT05058066
Study type	Interventional
Source	Radboud University
Contact
Status	Completed
Phase	N/A
Start date	June 24, 2019
Completion date	September 21, 2020

View Details

See also
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
Completed	`NCT04622059` - AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis	N/A
Terminated	`NCT02294812` - Effects of Cognitive Training on Speech Perception	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