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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03256097
Enrollment
21
Registered
2017-08-21
Start date
2018-07-25
Completion date
2022-05-31
Last updated
2023-01-12

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

Conditions

Cochlear Implantation

Keywords

Sound processing strategy

Brief 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.

Interventions

DEVICEXDP sound processing strategy - Period 0

XDP 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 1

XDP 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 1

Voice 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 2

XDP 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 2

Voice 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 3

XDP 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 3

Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend

DEVICEVoice Track

Voice 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

Sponsors

Oticon Medical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

A-B-A vs B-A-B

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Individuals aged between 18 and 70 years * Individuals with post-lingual hearing loss * Individuals with no language and speech production disorders * Individuals who are native speakers of English * Individuals meeting NICE candidacy criteria for CI surgery * Individuals undergoing primary unilateral cochlear implantation

Exclusion criteria

* Medical conditions contraindicating CI surgery * Individuals with anatomical anomalies of the auditory system * Individuals with additional mental health issues or and/or cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Speech perception scores in quite and in noise12 monthsSpeech perception with each intervention will be measured and a score between 0 to 100% will be obtained

Secondary

MeasureTime frameDescription
Patient reported outcome measure12 monthsGlasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention

Countries

United Kingdom

Outcome results

None listed

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