Clinical trial Recruiting at 1 site Observational Ages 6 to 18

Binaural listening and its effects on listening effort and development in Mandarin-speaking children with cochlear implants

Official title: Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants

Run by Guangdong Provincial People's Hospital · NCT07509788 · Data updated 2026-11-12

This study will test whether listening with two ears (two cochlear implants or a cochlear implant plus a hearing aid) reduces mental effort and helps brain, social, and daily-life development in Mandarin-speaking children aged 6–18 who use cochlear implants compared with children with normal hearing.

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Quick facts

Study typeObservational
Ages6 Years to 18 Years
SexAll
Enrollment360 (estimated)
SponsorGuangdong Provincial People's Hospital
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedOctober 1, 2030
Study endsOctober 1, 2030
Registry record updatedApril 15, 2026
Trial IDNCT07509788 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal participants are Mandarin-speaking children aged 6–18 with normal or corrected vision who either use unilateral or bilateral cochlear implants with good speech perception (CAP-II ≥ 5) or are age-matched children with normal hearing, and who can cooperate with testing and whose parent/guardian can give consent.

Probably not a fit

Children with diagnosed neurological or psychiatric disorders, those unable to cooperate with testing, those without parental/guardian consent, or children outside the 6–18 age range are unlikely to benefit from or be eligible for this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study comparing school-aged Mandarin-speaking children with cochlear implants to peers with normal hearing over three years. Participants complete hearing tests and measures of listening effort, cognitive development, social skills, and quality of life at repeated visits. The study compares children using one device versus binaural listening (bilateral CIs or CI plus hearing aid) to see whether reduced listening effort links to better developmental trajectories. No experimental treatments are given; researchers observe and measure real-world hearing and developmental outcomes.

Why it matters

Potential benefit: If successful, the results could clarify whether binaural hearing reduces listening effort and supports better cognitive, social, and daily functioning, helping clinicians and families make informed decisions about bilateral implantation or contralateral amplification.

How similar studies have gone: Prior research has shown binaural hearing can reduce listening effort and improve speech perception, but long-term links between listening effort and cognitive development in children remain relatively understudied.

Who can join: the full rules

Show full inclusion / exclusion criteria
CI Group Inclusion Criteria:

1. Aged 6-18 years
2. Normal vision, including corrected vision
3. Prelingual deafness with bilateral severe-to-profound sensorineural hearing loss, with unilateral or bilateral cochlear implantation
4. Good speech perception ability, with Categories of Auditory Performance-II (CAP-II) score of 5 or above
5. Cooperative with testing, with signed informed consent from parent or guardian

Normal-Hearing Control Group Inclusion Criteria:

1. Aged 6-18 years
2. Normal vision, including corrected vision
3. Bilateral pure-tone average at 250, 500, 1000, 2000, and 4000 Hz of 30 dB HL or less
4. Cooperative with testing, with signed informed consent from parent or guardian

Exclusion Criteria (All Groups):

1. Diagnosed neurological or psychiatric disorders
2. Absence of informed consent from parent or guardian
3. Other conditions deemed unsuitable for participation by the investigators

Where it's running

  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.