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

Oticon Medical

Status: Completed

Conditions: Cochlear Implantation

Treatments: Device: VG sound processing strategy - Period 3; Device: VG sound processing strategy - Period 1; Device: XDP sound processing strategy - Period 1; Device: XDP sound processing strategy - Period 2; Device: VG sound processing strategy - Period 2; Device: XDP sound processing strategy - Period 3; Device: Voice Track; Device: XDP sound processing strategy - Period 0

Study type: Interventional

Funder types: Industry

Identifiers

NCT03256097

PIC_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

XDP - VG - XDP

Experimental group

Description:

order of testing: XDP - VG - XDP

Treatment:

Device: XDP sound processing strategy - Period 1

Device: XDP sound processing strategy - Period 0

Device: VG sound processing strategy - Period 2

Device: XDP sound processing strategy - Period 3

Device: Voice Track

VG - XDP - VG

Experimental group

Description:

order of testing: VG - XDP - VG

Treatment:

Device: VG sound processing strategy - Period 3

Device: XDP sound processing strategy - Period 0

Device: XDP sound processing strategy - Period 2

Device: Voice Track

Device: VG sound processing strategy - Period 1