Bimodal Stimulation Compared to Unilateral Cochlear Implant

Hearing Impaired Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093830
• Other study ID #: bimodal hearing
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Mariam R Fam, Resident
• Phone: 01008630890
• Email: mariamrizkfam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impaired Children
• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. Epub 2007 Nov 29. — View 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. Erratum in: J Acoust Soc Am. 2014 May;135(5):3127. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison the audiometric thresholds in bimodal fitting users condition and cochlear implant alone condition	By using pure tone and speech audiometer the pure tone audiometry will be done in the free ?eld with a speaker at 0° azimuth and the mean threshold in speech frequencies of 0.5, 1, 2 and 4 kilohertz will be determined.	Baseline
Primary	Comparison between speech discrimination score in bimodal fitting condition and cochlear implant alone condition.	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.	Baseline
Primary	Evaluation of speech perception ability in noise under bimodal fitting a condition and cochlear implant alone condition	By speech perception in noise (SPIN) test using Compact disc on compact discs player.	Baseline
Primary	Comparison of early speech perception in bimodal fitting condition and cochlear implant alone condition	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	Baseline
Primary	Comparison between the speech reception threshold in bimodal fitting condition and cochlear implant alone condition.	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	Baseline