Bimodal Stimulation Compared to Unilateral Cochlear Implant

NCT ID: NCT04093830

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Hearing Impaired Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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pre-lingually deafened children with cochlear implant

pre-lingually deafened children with cochlear implant who continuously used bimodal hearing.

Group Type EXPERIMENTAL

hearing aid

Intervention Type DEVICE

hearing aid can be used in their non- implanted ear with residual hearing

Interventions

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hearing aid

hearing aid can be used in their non- implanted ear with residual hearing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Rizk Fam

Resident doctor -Assiut university hospital-Assiut

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enass S Mohamed, Professor

Role: PRINCIPAL_INVESTIGATOR

Professor of Audio-vestibular medicine,Assiut University,Egypt.

Central Contacts

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Mariam R Fam, Resident

Role: CONTACT

01008630890

Amira M Eloseily, Lecturer

Role: CONTACT

01095495110

References

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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.

Reference Type BACKGROUND
PMID: 18057874 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24437856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29451107 (View on PubMed)

Other Identifiers

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bimodal hearing

Identifier Type: -

Identifier Source: org_study_id

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