- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913517
Effect of Hearing Aid Versus Cochlear Implant on Hearing and Speech Recognition in Children
This study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss.
This research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. Data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic. Descriptive and inferential statistical analyses will be used to determine differences between the groups.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Punjab
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Lahore, Punjab, Pakistan
- Society for Audiological and Developmental Ailments (SADA) - Audiology Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
This study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss.
This research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. Data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic
Description
Inclusion Criteria:
- Children with 6-18 years of age
- Bilateral hearing aid users with Moderate to Severe degree Sensorineural hearing loss.
- Unilateral Cochlear Implant users with Severe to Profound degree Sensorineural hearing loss and no amplification to other ear.
- Consistent use of hearing aid or cochlear implant for more than 1 year.
- Known or presumed early onset of hearing loss before 3 years of age
- Urdu as primary language of education
- Enrolled in rehabilitation program (school or pre-school for hearing impaired children) focused on oral communication.
Exclusion Criteria:
- Children below 6 years or above 18 years
- Children with less than 1 year of consistent use of hearing aids or cochlear implant
- Children with cognitive, neurological or developmental disorders."
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aided Audiometry
Time Frame: 12 Months
|
the hearing ability of individual using hearing aids or cochlear implant is measured in a Free Field Testing Environment using Pure Tones at frequencies 250Hz to 8000Hz. Interpretation: Results are plotted on Audiogram, showing the lowest level in decibel (dB HL) at which patient can detect sounds with their hearing aid or cochlear implant. 20-30dB HL Excellent aided thresholds (satisfactory) 31-40 dBHL Mild aided thresholds (good) 41-60 dBHL Moderate aided hearing thresholds (average) More than 60dBHL Severe aided hearing thresholds (poor) |
12 Months
|
|
Speech Perception Test
Time Frame: 12 Months
|
Evaluated using Phonetically Balanced Monosyllabic word list in Urdu in both quiet and noisy environment. Interpretation: The score is expressed as a percentage of correctly identified words under specified listening condition. 90- 100% Normal or Slight difficulty 70-89% Mild difficulty 50-69% Moderate difficulty Below 50% Severe difficulty or poor word recognition Score |
12 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall23/805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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