Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

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 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

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