Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

An observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.

Study Overview

• Status: Completed
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Device: Hearing Aid

Detailed Description

People with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. A cochlear implant (CI) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients.

Currently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation.

The PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss.

The current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's and St. Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at St. Thomas' Hearing Implant Centre

Description

Inclusion Criteria:

• Adult
• Has unilateral Cochlear Implant
• Consistent use of Hearing Aid
• Obtains some benefit in speech discrimination from hearing aid (> 20% AB words)
• Post-lingually deafened
• Fluent English

Exclusion Criteria:

• Longstanding significant asymmetry (> 20 dB HL 4 frequency average) in hearing where the unimplanted ear is the worse ear
• Inconsistent Hearing Aid use
• Significant conductive hearing loss (> 20 dB HL 4 frequency average)
• Using Electro-Acoustic stimulation Cochlear Implant
• Aetiology of hearing loss likely associated with auditory neuropathy
• Significantly abnormal appearance of cochlea or cochlear nerve

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PEPS-C speech test battery	Test battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)	Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AB words speech test	Word speech discrimination test in quiet, 30 words presented, scored as % correct, higher score better outcome	Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
SSQ12 Questionnaire	Speech Spatial Qualities patient reported outcome measure, scored out of 120 higher scores better outcome	Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
Unaided Soundfield Audiometry	Soundfield hearing test without Cochlear Implant or Hearing Aid	Tested at one time point at day 1 of study after recruitment
BKB sentences speech test	Sentences speech discrimination test in quiet, 100 words presented, 50 male, 50 female voice, scored as %	Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 23, 2023

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: 307417

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No