Evaluation of Middle Ear Implantation

Status Completed

Clinical Trial Summary

The middle ear implant are used for patients with mild to severe sensorineural hearing loss, who cannot benefit from conventional hearing aids because of medical reasons such as chronic external otitis or external skin irritation. The device is also available for patients who are dissatisfied with the conventional hearing aids because of poor sound quality, feedback or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe and about more than 600 patients in France. The aim of the present study is to compare in a randomized study the performances of the system to those of the conventional hearing aid in patients with similar degree of hearing loss.

Clinical Trial Description

Objective: The main objective of this study is to demonstrate that the middle ear implant increases the hearing in terms of speech intelligibility in quiet and noisy conditions, in patients who have no further benefit of their conventional hearing aid. The quality of life of these patients will be evaluated as well as the tolerance of the middle ear implant after 6 months.

Design of the study: 420 patients with mid or severe hearing loss will be included. They will have for 3 months the best conventional hearing aid adapted to their hearing loss. The first 84 patients who will not have a benefit of this hearing aid, will be randomised in two groups. The patients of the first group will be operated as soon as possible, the surgery of the patients of the second group will be delayed by 6 months. The whole duration of the study is 48 months.

Evaluation criteria: Audiological testing (pure-tone hearing thresholds, speech comprehension in quiet and noise), and subjective evaluation using self-assessment scales will be performed before and 6 months after the implantation in the two groups. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT00451503
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	March 2007
Completion date	June 2012

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