Brief Title
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
Official Title
Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
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).
Study Type
Interventional
Primary Outcome
Satisfaction questionnaire
Secondary Outcome
Speech comprehension in quiet
Condition
Sensorineural Hearing Loss
Intervention
Satisfaction questionnaire
Study Arms / Comparison Groups
Adults and children above 14 years old
Description: Visit 1: Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
98
Start Date
October 2, 2017
Completion Date
January 2019
Primary Completion Date
January 2019
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Christophe Vincent, MD, PROF, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT03288753
Organization ID
PIC_14
Responsible Party
Sponsor
Study Sponsor
Oticon Medical
Study Sponsor
Christophe Vincent, MD, PROF, Principal Investigator, Hôpital Roger Salengro CHRU de Lille
Verification Date
August 2018