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Clinical Trials/NCT03256097
NCT03256097
Completed
Not Applicable

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

Oticon Medical2 sites in 1 country21 target enrollmentJuly 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cochlear Implantation
Sponsor
Oticon Medical
Enrollment
21
Locations
2
Primary Endpoint
Speech perception scores in quite and in noise
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 25, 2018
End Date
May 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Speech perception scores in quite and in noise

Time Frame: 12 months

Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained

Secondary Outcomes

  • Patient reported outcome measure(12 months)

Study Sites (2)

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