NCT05923203 Combined Electric and Acoustic Hearing (EAS) in Children and Adults
| NCT ID | NCT05923203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hearts for Hearing |
| Condition | Cochlear Implant |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-12-05 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-12-05 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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). 2. 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. 3. 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). 4. No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment. 5. 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: 1. Nonverbal intelligence standard score \< 85 (for any participant). 2. MoCA or HI-MoCA score \< 26 for adult participants.
Contact & Investigator
René H Gifford, PhD
PRINCIPAL INVESTIGATOR
Hearts for Hearing
Frequently Asked Questions
Who can join the NCT05923203 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Cochlear Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05923203 currently recruiting?
Yes, NCT05923203 is actively recruiting participants. Contact the research team at rene.gifford@heartsforhearing.org for enrollment information.
Where is the NCT05923203 trial being conducted?
This trial is being conducted at Edmond, United States, Nashville, United States, Austin, United States, Madison, United States.
Who is sponsoring the NCT05923203 clinical trial?
NCT05923203 is sponsored by Hearts for Hearing. The principal investigator is René H Gifford, PhD at Hearts for Hearing. The trial plans to enroll 160 participants.