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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorHearts for Hearing

About this trial

There is a rapidly growing population of adult and pediatric cochlear implant (CI) recipients with acoustic hearing preservation in the implanted ear(s) allowing for combined Electric and binaural Acoustic Stimulation (EAS). Despite the rapid technological and surgical advancements that have led to this increased prevalence, there is limited research on EAS outcomes-particularly for pediatric EAS listeners-including the expected trajectory of benefit following EAS fitting and underlying mechanisms driving benefit in EAS users of all ages. Thus, the purpose of this project is to provide a comprehensive description of behavioral and electrophysiologic measures of binaural hearing in adults and children both with normal hearing and EAS users.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pediatric EAS: aged 5-17; Adult EAS: aged 18+ years

At least one CI and bilateral mild to profound sensorineural hearing loss with unaided audiometric thresholds ≤ 80 dB HL at 125 and 250 Hz, in both ears.

Willingness to use EAS technology in the implanted ear(s) to be verified via data logging

Nonverbal cognitive abilities within the typical range

Disqualifiers

single-sided deafness (SSD)

Trial population

Individuals with steeply sloping sensorineural hearing loss in both ears

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • binaural processing over time

    Behavioral

    This study will not provide an intervention, but will study the effects of hearing technology on binaural processing for adults and children with bilateral steeply sloping sensorineural hearing loss

  • binaural processing over time for children and adults with normal hearing

    Behavioral

    Adults and children with normal hearing will be studied over time to characterize binaural processing and associated effects on speech perception in complex listening scenarios and spatial hearing abilities.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Children with normal hearing2 interventions
Group B: Adults with normal hearing1 intervention
Group C: Children with bilateral steeply sloping sensorineural hearing loss1 intervention
Group D: Adults with bilateral steeply sloping sensorineural hearing loss1 intervention

Trial outcomes

Primary outcomes

1

EAS benefit for speech recognition in noise and spatial hearing abilities

For children and adults who are pursuing cochlear implantation with acoustic hearing preservation, we will describe the rate of hearing preservation following implantation. This is critical as it is well-known that individuals with acoustic hearing preservation achieve significantly higher scores on tasks of speech recognition in noise, particularly with diffuse noise.

Time frame
2 years
2

Binaural cue sensitivity (interaural time and level differences)

For children and adults with precipitously sloping, high-frequency sensorineural hearing loss pursuing cochlear implantation, we will describe binaural cue sensitivity pre- and post-implant.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hearts for Hearing

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator