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CompletedNCT03256097

Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Oticon Medical · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The study aims to compare two different cochlear implant sound processing strategies. All the participants will start off with a sound processing strategy called the XDP (extended performance). At the 3 month stage, half of the participants would randomly be selected and offered a sound processing strategy called the Voice Guard. Following that, the sound processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th month of cochlear implant use.

Detailed description

Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear implant based on the levels of the listening environment. Hence, it can adapt to soft, medium or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot alter the cochlear implant output according to the levels of the listening environment. In the study we are hypothesising that the Voice Guard sound processing strategy will perform better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels. Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study design has been adopted. In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track will also be evaluated. The Voice Track is designed to reduce the adverse effect of background noise on cochlear implant speech perception.

Conditions

Interventions

TypeNameDescription
DEVICEXDP sound processing strategy - Period 0XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
DEVICEXDP sound processing strategy - Period 1XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
DEVICEVG sound processing strategy - Period 1Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
DEVICEXDP sound processing strategy - Period 2XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
DEVICEVG sound processing strategy - Period 2Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
DEVICEXDP sound processing strategy - Period 3XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
DEVICEVG sound processing strategy - Period 3Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
DEVICEVoice TrackVoice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants

Timeline

Start date
2018-07-25
Primary completion
2022-05-31
Completion
2022-05-31
First posted
2017-08-21
Last updated
2023-01-12

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03256097. Inclusion in this directory is not an endorsement.

Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System (NCT03256097) · Clinical Trials Directory