NCT05923203 · Hearts for Hearing
Combined Electric and Acoustic Hearing (EAS) in Children and Adults
What this study is about
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS).
View original scientific description
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual hearing and can benefit from electric and acoustic hearing in the same ear. This is called Electric Acoustic Stimulation (EAS). Many studies have shown that adult EAS users show significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. Even though this type of hearing is becoming more common, there is limited research on how it can be beneficial to children with CIs. The benefits of this study are a greater understanding of the participant's speech understanding, binaural processing, and spatial hearing. The results will help audiologists and researcher better understand how cochlear implants work, specifically when using electric and acoustic hearing in the same ear.
Interventions
OTHER
Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
This is a clinical fitting of an FDA approved EAS system for study participants that have received or who are scheduled to receive a CI based on clinical recommendations (i.e. not study related). The investigators will activate the CI sound processor's integrated HA circuit to allow for low-frequency acoustic amplification and mid-to-high frequency electric stimulation in the implanted ear(s) using recommended and accepted clinical practices and audiologic verification. EAS fitting will be completed using FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
Primary outcome measures
Change in BEL sentence score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
Time frame: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)
Speech recognition will be assessed with co-located (S0N0) and spatially separated noise (S0N90 and S0N270) using the BEL sentences with two different male or female talkers as the maskers. Target speech will be fixed at 70 dB SPL for both speech stimuli and the investigators will assess performance for two listening conditions: CI+HA and CIHA+HA.
Change in BKB-SIN score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
Time frame: This will be measured at multiple time points including at or within 1 month of EAS activation (adults & peds), 6 months (adults & peds), 12 months (adults & peds, and 24 months (peds)
Speech recognition will be assessed with co-located (S0N0) and spatially separated noise (S0N90 and S0N270) using the BKB-SIN test with multi-talker babble as the masker. Target speech will be fixed at 70 dB SPL for both speech stimuli and the investigators will assess performance for two listening conditions: CI+HA and CIHA+HA.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Children aged 5 to 17 years of age with either normal hearing (n=40) or at least 1 cochlear implant (CI) and binaural low-frequency acoustic hearing (n=40); adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40).
- Experimental participants must have at least one CI and bilateral mild to severe sensorineural hearing loss For CI participants, audiometric thresholds in the non-CI ear must be consistent with at least a mild sensorineural hearing loss; that is, the investigators will not be enrolling participants with single-sided deafness (SSD) For CI participants, unaided audiometric thresholds must be less than or equal to 80 dB HL for 125 and 250 Hz, in both ears.
- Nonverbal cognitive abilities within the typical range for all participants; adult participants must also pass cognitive screening via Montreal Cognitive Assessment (MoCA or HI-MoCA).
- No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
- Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.
Exclusion criteria
- Nonverbal intelligence standard score \< 85 (for any participant).
- MoCA or HI-MoCA score \< 26 for adult participants.
Where
- Edmond, Oklahoma
- Nashville, Tennessee
- Austin, Texas
- Madison, Wisconsin
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations