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Clinical Trials/NCT03288753
NCT03288753
Completed
Not Applicable

Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors

Oticon Medical9 sites in 1 country98 target enrollmentOctober 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sensorineural Hearing Loss
Sponsor
Oticon Medical
Enrollment
98
Locations
9
Primary Endpoint
Satisfaction questionnaire
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.

Detailed Description

Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries...). Some improvements available on the Neuro 2 may be particularly interesting for children. The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1. The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).

Registry
clinicaltrials.gov
Start Date
October 2, 2017
End Date
January 11, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • informed consent
  • Native French speaker or fluent French speaker
  • Patient already fitted with one or two speech processor Neuro 1 for at least 5 months

Exclusion Criteria

  • vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
  • No Social security affiliation
  • non-compliant patient

Outcomes

Primary Outcomes

Satisfaction questionnaire

Time Frame: 15 minutes

The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.

Secondary Outcomes

  • Speech comprehension in quiet(15 mins)
  • Speech comprehension in Noise(15 mins)
  • French Quick Sin(5 mins)

Study Sites (9)

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