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

Not Applicable

Completed

• Conditions: Cochlear Implantation
• Interventions: Device: XDP sound processing strategy - Period 0; Device: VG sound processing strategy - Period 1; Device: XDP sound processing strategy - Period 1; Device: VG sound processing strategy - Period 2; Device: XDP sound processing strategy - Period 2; Device: XDP sound processing strategy - Period 3; Device: VG sound processing strategy - Period 3; Device: Voice Track

• Registration Number: NCT03256097
• Lead Sponsor: Oticon Medical

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.

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Study Start: 2018-07-25
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
XDP - VG - XDP	XDP sound processing strategy - Period 0	order of testing: XDP - VG - XDP
VG - XDP - VG	VG sound processing strategy - Period 1	order of testing: VG - XDP - VG
XDP - VG - XDP	VG sound processing strategy - Period 2	order of testing: XDP - VG - XDP
XDP - VG - XDP	XDP sound processing strategy - Period 3	order of testing: XDP - VG - XDP
XDP - VG - XDP	Voice Track	order of testing: XDP - VG - XDP
VG - XDP - VG	XDP sound processing strategy - Period 0	order of testing: VG - XDP - VG
XDP - VG - XDP	XDP sound processing strategy - Period 1	order of testing: XDP - VG - XDP
VG - XDP - VG	XDP sound processing strategy - Period 2	order of testing: VG - XDP - VG
VG - XDP - VG	VG sound processing strategy - Period 3	order of testing: VG - XDP - VG
VG - XDP - VG	Voice Track	order of testing: VG - XDP - VG

Primary Outcome Measures

Name	Time	Method
Speech perception scores in quite and in noise	12 months	Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome measure	12 months	Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention

Trial Locations

Locations (2)

Addenbrooke's Hospital, Cambridge University Hospitals Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom