Combined Electric and Acoustic Hearing (EAS) in Children and Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorHearts for Hearing
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Nonverbal intelligence standard score < 85 (for any participant).
MoCA or HI-MoCA score < 26 for adult participants.
Trial design
Design model
Parallel
Treatments tested in this trial
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)
Other interventionThis 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.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: Adult use of EASExperimental treatment 1 intervention
Group B: Pediatric use of EASExperimental treatment 1 intervention
Group C: Children with Normal HearingNo intervention 0 interventions
Group D: Adults with Normal HearingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in BEL sentence score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
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.
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)2
Change in BKB-SIN score demonstrating EAS benefit for speech recognition in noise (CIHA+HA - CI+HA)
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.
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)Secondary outcomes
1
EAS benefit for minimal audible angle (MAA) (CIHA+HA - CI+HA)
MAA thresholds will be obtained by presenting 2 successive stimuli from different positions in the horizontal plane and requesting that the listener indicate whether the 2nd stimulus was to the left or to the right of the standard. Noise stimuli will include a BBN (100-8000 Hz) and LF noise (100-800 Hz). Three listening conditions will be tested: 1) bilateral HA (HA+HA), 2) bimodal (CI+HA), and EAS (CIHA+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)2
ITD sensitivity
ITD thresholds will be measured using tonal and noise-band carriers. This task will be completed using both acoustic and electric stimulation with the latter achieved via direct connection to the CI sound processor allowing for investigation of binaural interference.
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)3
ILD sensitivity
ILD thresholds will be measured using tonal and noise-band carriers. This task will be completed using both acoustic and electric stimulation with the latter achieved via direct connection to the CI sound processor allowing for investigation of binaural interference.
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)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
Source ClinicalTrials.gov