Speech DisordersNCT06913517
Effect of Hearing Aid Versus Cochlear Implant on Hearing and Speech Recognition in Children
An observational study of Speech Disorders, run by Superior University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Speech Disorders
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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."
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Society for Audiological and Developmental Ailments (SADA) - Audiology Clinic
Lahore, Punjab Province
About this study
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.
Read the detailed description
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.
- Conditions
- Speech Disorders
- Medical subject headings
- Speech Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Aided Audiometry
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)
Measured: 12 Months
Speech Perception Test
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech DisordersStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913517
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/805
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hearing Aid Versus Cochlear Implant on Hearing and Speech Recognition in Children
- ClinicalTrials.gov ID
- NCT06913517
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/805
- Conditions
- Speech Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Speech Disorders, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aided Audiometry (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.