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Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06128161
Enrollment
16
Registered
2023-11-13
Start date
2022-08-30
Completion date
2023-03-23
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss

Brief summary

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.

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.

Interventions

DEVICEHearing Aid

Contralateral Hearing Aid to Cochlear Implant

Sponsors

University of Manchester
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PEPS-C speech test batteryTested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditionsTest battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)

Secondary

MeasureTime frameDescription
SSQ12 QuestionnaireTested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditionsSpeech Spatial Qualities patient reported outcome measure, scored out of 120 higher scores better outcome
Unaided Soundfield AudiometryTested at one time point at day 1 of study after recruitmentSoundfield hearing test without Cochlear Implant or Hearing Aid
BKB sentences speech testTested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditionsSentences speech discrimination test in quiet, 100 words presented, 50 male, 50 female voice, scored as %
AB words speech testTested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditionsWord speech discrimination test in quiet, 30 words presented, scored as % correct, higher score better outcome

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026