Long-term hearing and speech outcomes after cochlear implants

Is this trial a fit for you?

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 longitudinal observational study that follows patients with severe or greater hearing loss who are scheduled to receive cochlear implants at the Eye & ENT Hospital of Fudan University. Participants will complete standardized hearing, speech perception, and quality-of-life measures before surgery and at multiple follow-up visits after implantation. Outcomes will be compared across age cohorts and clinical subtypes to identify patterns in recovery and benefit. The goal is to generate data that can inform more individualized auditory and speech rehabilitation approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with severe or greater hearing loss (≥65 dB) scheduled to receive cochlear implant (CI) treatment.
* No restrictions on age or gender.
* Native language is Mandarin Chinese.
* The subject and/or their legal guardian must provide informed consent prior to the study, voluntarily sign a written informed consent form, and be willing to undergo follow-up assessments at the specified time points.
* Ability to communicate effectively with the researcher with the help of a guardian and comply with the researcher's requirements. For young children without mature language skills, ability to cooperate with the help of a guardian.
* The subject's guardian has a correct understanding of the trial and realistic expectations of potential benefits.

Exclusion Criteria:

* Presence of other severe diseases unsuitable for cochlear implantation surgery.
* Significant psychological problems or mood disorders (e.g., notable anxiety, depression, or behavioral disorders) that would preclude cooperation with training and follow-up.
* Neurological diseases (e.g., epilepsy, cerebral palsy) that may affect auditory processing ability.
* Concurrent participation in other interventional studies involving drugs or behavioral interventions that may affect auditory rehabilitation during the study period.
* Any other condition considered by the investigator to make the subject unsuitable for participation in this clinical study.

Where it's running

• Eye & ENT Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Yilai Shu, M.D.& Ph.D.
• Email: yilai_shu@fudan.edu.cn
• Phone: +86 21 6437 7134

Similar studies

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

• BEARS directional-listening training to improve hearing in older children and teens with two cochlear implants

  This trial tests whether 3 months of the BEARS virtual-reality directional listening training, added to usual care, helps 8–16 year olds with two cochlear implants hear better in noisy places, reduce listening effort, and improve vocabulary and quality of life.

  Recruiting at 12 sites Guy's and St Thomas' NHS Foundation Trust · Birmingham, Birmingham and 12 other locations · NCT05808543

• Cisplatin-related (Ear) Hearing Loss and Balance Issues in Head and Neck Cancer Patients

  This observational study tests whether hearing loss, tinnitus, and balance problems occur in head and neck cancer patients treated with cisplatin chemoradiotherapy compared with those receiving only radiotherapy, including optional genetic tests for susceptibility.

  Recruiting Paracelsus Medical University · Nuremberg, Bavaria · NCT06929468

• Using robotics and electrocochleography for cochlear implant surgery

  This study is testing if using a robotic system during cochlear implant surgery can help improve outcomes for people with hearing loss.

  Recruiting iotaMotion, Inc. · Iowa City, Iowa · NCT06664710

• Understanding listening effort in cochlear implant users

  This study tests how much effort people with cochlear implants need to understand speech compared to those with normal hearing, using speech tests and measuring pupil size to see how hard they are working to listen.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06516575

• Using mild cooling during cochlear implant surgery to preserve hearing

  This study tests if using mild cooling during cochlear implant surgery can help people with severe hearing loss keep some of their natural hearing.

  Recruiting Restorear Devices LLC · Miami, Florida · NCT06375278

• Comparing speech perception in cochlear implant patients and those receiving gene therapy for hearing loss

  This study is trying to see how well people with cochlear implants hear and understand speech compared to those who have received gene therapy for hearing loss.

  Recruiting Eye & ENT Hospital of Fudan University · Beijing, Beijing Municipality and 5 other locations · NCT06237790

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.