N/A N=45 Treatment

Interaural Frequency and Loudness Mismatch in SSD CI Users

Outcomes

Bottom Line

View on ClinicalTrials.gov: NCT05494632 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Speech Understanding in Noise, Measured With the R-Space Test Environment. The R-Space Test Environment Simulates Speech Understanding in a Noisy Restaurant. — -3.0; -1.9; -4.0; -2.9 signal-noise-ratio in decibels (dB) — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Treatment-modifications to CI speech processor program. Specifically reducing interaural frequency mismatch in experienced SSD-CI recipients. (Device); Treatment-modifications to CI speech processor program to reduced interaural frequency mismatch in newly implanted SSD-CI recipients. (Device); Treatment-modifications to CI speech processor program to reduced interaural loudness mismatch in experienced SSD-CI recipients. (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Jul 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Speech Understanding in Noise, Measured With the R-Space Test Environment. The R-Space Test Environment Simulates Speech Understanding in a Noisy Restaurant.	-3.0; -1.9; -4.0; -2.9; -3.6; -2.9	<0.001 sig

Summary

Interaural loudness and pitch mismatch in single-sided deaf cochlear implant (SSD-CI) recipients reduces binaural processing cues and contributes to performance outcomes, specifically speech understanding in noise and localization. The study aims to improve binaural cues through speech processor program modifications that reduce interaural mismatches.

Eligibility Criteria

Inclusion Criteria

Participants for the proposed study will be adults with single-sided deafness. Participants will have at least 6 months experience with their cochlear implant or will be newly implanted with the cochlear implant.

Inclusion criteria for the experienced CI user group and the newly implant group are as follows:

18 years of age and older
Postlingual onset of SSD
Pure tone average (PTA) at 500, 1000, and 2000 Hz of less than or equal to 30 dB HL in the contralateral ear, known as the normal hearing ear
Implanted with or chosen to be implanted with a Nucleus cochlear implant
Full insertion of electrode array

Exclusion Criteria

• Not meeting the inclusion criteria

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Data sourced from ClinicalTrials.gov (NCT05494632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.