Binaural Cue Sensitivity in Children and Adults With Combined Electric and Acoustic Stimulation

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: t
View:

• 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.

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University Of Texas at Austin
RECRUITING
Austin
Wisconsin
University Of Wisconsin Madison
RECRUITING
Madison
Contact Information
Primary
Jonathan Neukam, AuD
jd.neukam@vumc.org
615-936-5000
Time Frame
Start Date: 2022-12-05
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 160
Treatments
Experimental: Adult use of EAS
Clinical intervention; Adults with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
Experimental: Pediatric use of EAS
Clinical intervention; Children with CI and the fitting of electric and acoustic stimulation (EAS) technology in the implanted ear(s).
No_intervention: Children with Normal Hearing
Children with normal hearing; acoustic only
No_intervention: Adults with Normal Hearing
Adult with normal hearing; acoustic only
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov