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

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.

Study Overview

• Status: Completed
• Conditions: Cochlear Implantation
• Intervention / Treatment: Device: XDP sound processing strategy - Period 0; Device: XDP sound processing strategy - Period 1; Device: VG sound processing strategy - Period 2; Device: XDP sound processing strategy - Period 3; Device: Voice Track; Device: VG sound processing strategy - Period 1; Device: XDP sound processing strategy - Period 2; Device: VG sound processing strategy - Period 3

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Addenbrooke's Hospital, Cambridge University Hospitals Trust
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XDP - VG - XDP; order of testing: XDP - VG - XDP	Device: XDP 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.; Device: XDP 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.; Device: VG 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; Device: XDP 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.; Device: Voice 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
Experimental: VG - XDP - VG; order of testing: VG - XDP - VG	Device: XDP 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.; Device: Voice 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; Device: VG 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.; Device: XDP 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.; Device: VG 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measure	Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention	12 months

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: James Tysome, Consultant Head and Neck Surgeon, Addenbrookes Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2018
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Sound processing strategy
• Other Study ID Numbers: PIC_12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No