Clinical trial NCT04093830: Bimodal Stimulation Compared to Unilateral Cochlear Implant
Official title: Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Impaired Children
Keywords: Hearing Loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 25
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition
timeFrame: Baseline
measure: Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.
timeFrame: Baseline
measure: Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition
timeFrame: Baseline
measure: Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition
timeFrame: Baseline
measure: Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Audio-vestibular medicine,Assiut University,Egypt.
name: Enass S Mohamed, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29.
citation: Kokkinakis K, Pak N. Binaural advantages in users of bimodal and bilateral cochlear implant devices. J Acoust Soc Am. 2014 Jan;135(1):EL47-53. doi: 10.1121/1.4831955.
citation: Tao DD, Liu JS, Yang ZD, Wilson BS, Zhou N. Bilaterally Combined Electric and Acoustic Hearing in Mandarin-Speaking Listeners: The Population With Poor Residual Hearing. Trends Hear. 2018 Jan-Dec;22:2331216518757892. doi: 10.1177/2331216518757892.