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Completed

NCT Number: NCT05494632

Interaural Frequency and Loudness Mismatch in SSD CI Users

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.

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Key information

Conditions

Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

Effective binaural processing depends on similar loudness growth functions at each ear. The use of interaural level differences (ILDs), perceived as loudness differences, to locate sound is critical given the inability of cochlear implant (CI) recipients to use interaural time differences (ITDs) in binaural processing. In CI recipients with single-sided deafness (SSD), perceived interaural loudness differences may not be valid indicators of interaural level differences because the CI compresses amplitude. Studies suggest better preservation of ILDs may contribute to improved localization and understanding in noise. Since SSD-CI recipients use only one device, an approach to improve their use of ILDs is to match perceived loudness at each ear.

Binaural processing is also affected when signals of equal frequency are not matched in pitch at each ear. In bilateral CI recipients, the investigators found that the greater the pitch mismatch between ears, the poorer the speech understanding in noise. The investigators want to extend this work to SSD-CI recipients. Through CI program modifications, the study aims to decrease the pitch and loudness mismatch between the CI ear and the normal hearing ear to improve binaural listening abilities, specifically speech understanding in noise and sound localization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment-modifications to CI speech processor program. Specifically reducing interaural frequency mismatch in experienced SSD-CI recipients.

Device

We will modify the CI speech processor program to reduce interaural frequency mismatch between the CI ear and the contralateral ear in experienced CI recipients with SSD.

Treatment-modifications to CI speech processor program to reduced interaural frequency mismatch in newly implanted SSD-CI recipients.

Device

We will modify the CI speech processor program to reduce interaural frequency mismatch between the CI ear and the contralateral ear in newly implanted CI recipients with SSD.

Treatment-modifications to CI speech processor program to reduced interaural loudness mismatch in experienced SSD-CI recipients.

Device

We will modify the CI speech processor program to reduce interaural loudness mismatch between the CI ear and the contralateral ear in experienced CI recipients with SSD.

Primary outcomes

  1. Speech Understanding in Noise, Measured With the R-Space Test Environment. The R-Space Test Environment Simulates Speech Understanding in a Noisy Restaurant.

    Time frame: Participants were tested in the R-Space twice with each speech processor program, e.g., everyday or default program and modified program. The testing was carried out within a 2-3 month time period, and after using each program for at least 6 weeks.

    Participants speech understanding was evaluated in the R-Space test environment with two speech processor programs, an everyday or default program and a modified program. The modified program was created to reduce interaural frequency or loudness mismatch between participants' CI ear and normal hearing ear. The R-Space simulates listening in a noisy restaurant, a real-world listening situation. The score is a signal-to-noise ratio that reflects 50% speech understanding in noise. Participants are surrounded by 8 loudspeakers with restaurant noise from all 8. A sentence is presented from the front loudspeaker. Participants repeat back what they hear. The noise is adjusted adaptively. For a correct response, the noise is increased; it is decreased for an incorrect response. This provides signal-to-noise ratio (SNR) for 50% speech understanding. The average score for participants with normal hearing is -5 dB SNR. A lower number represents better performance than a higher number.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Cochlear

Registry information

Official study title

Effects of Interaural Frequency and Loudness Mismatch on SSD-CI Performance

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 10, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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