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Bimodal Stimulation Compared to Unilateral Cochlear Implant

Advantages of Bimodal Stimulation Compared to Unilateral Cochlear Implant Use in Children With Hearing Loss

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04093830
Enrollment
25
Registered
2019-09-18
Start date
2020-06-01
Completion date
2022-01-01
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impaired Children

Keywords

Hearing Loss

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.

Interventions

DEVICEhearing aid

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone conditionBaselineBy 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.
Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.BaselineThe 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 conditionBaselineBy 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 conditionBaselineThe 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.BaselineSpeech 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

Contacts

Primary ContactMariam R Fam, Resident
mariamrizkfam@gmail.com01008630890
Backup ContactAmira M Eloseily, Lecturer
amiraos@aun.edu.eg01095495110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026