Bimodal Stimulation Compared to Unilateral Cochlear Implant

Not Applicable

• Conditions: Hearing Impaired Children

• Registration Number: NCT04093830
• Lead Sponsor: Assiut University

Brief Summary

The majority of studies about bimodal hearing advantages have been conducted on adults but scant relevant studies into pediatric users, therefore more comparative studies are required to compare the effect of bimodal stimulation to unilateral cochlear implant use in children with severe to profound sensori-neural hearing loss .

Detailed Description

There are now many recipients of unilateral cochlear implants who have usable residual hearing in the non-implanted ear. To avoid auditory deprivation and to provide binaural hearing, a hearing aid or a second cochlear implant can be fitted to that ear. When bilateral cochlear implant cannot be used for patients with bilateral hearing impairment, a hearing aid can be used in their non- implanted ear with residual hearing. This is because patients with bilateral hearing loss need bilateral stimulation to develop the neural pathway required for central processing of binaural hearing.

Study Timeline

• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2019-09-14
• Study First Posted: 2019-09-18
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18
• Study Start: 2020-06-01
• Primary Completion: 2021-06-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. The lack of middle-ear infection.
2. Normative intelligence.
3. The lack of auditory neuropathy disorder .
4. Residual hearing in the non-implanted ear.

Exclusion Criteria

1. Middle ear infection..
2. Below average intelligence.
3. Auditory neuropathy disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.	Baseline	The speech discrimination score is a measure as a percentage of words from a standardized list presented at suprathreshold levels that are recognized and repeated by the patient.; a higher score on the speech discrimination test is better; Interpreting speech discrimination score : 100-90% Means Excellent or Normal speech discrimination score, 89-75% Means Good speech discrimination score, 74-60% Means Fair speech discrimination score, 59-50 % Means Poor speech discrimination score\& \<50% Means Very Poor speech discrimination score.
Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition	Baseline	By speech perception in noise (SPIN) test using Compact disc on compact discs player.
Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition	Baseline	The test will be done starting from a low level using the manual and standard scoring forms of Early speech perception test ( ESP) by using : Compact disc , full-color picture cards, Toys ,digitally remastered sounds, and an All Words menu
Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.	Baseline	Speech reception threshold is the minimum intensity in decibels at which a patient can understand 50% of spoken words from a closed set list of disyllabic words
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition	Baseline	By using pure tone and speech audiometer the pure tone audiometry will be done in the free field with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.