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OpenTrials
Active, Not Recruiting

NCT Number: 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Society for Audiological and Developmental Ailments (SADA) - Audiology Clinic

Lahore, Punjab Province, Pakistan

About this study

The study aims to provide evidence-based guidance for audiologists, educators, and caregivers regarding optimal device selection and management. By identifying the strengths and limitations of each intervention, the findings will contribute to improved rehabilitation strategies, ultimately enhancing auditory and speech outcomes in children with hearing loss. This research holds significance for advancing clinical practices in pediatric audiology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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