Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

Oticon Medical

Status: Completed

Conditions: Cochlear Hearing Loss; Sensorineural Hearing Loss

Treatments: Other: Satisfaction questionnaire; Behavioral: VRB (Vocale Rapide dans le Bruit); Behavioral: Speech intelligibility in noise; Behavioral: Speech intelligibility in quiet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03288753

PIC_14

Details and patient eligibility

About

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.

Full 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).

Enrollment: 98 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Adults and children above 14 years old

Experimental group

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

Treatment:

Other: Satisfaction questionnaire

Behavioral: VRB (Vocale Rapide dans le Bruit)

Behavioral: Speech intelligibility in quiet

Behavioral: Speech intelligibility in noise

children up to 14 years old

Experimental group

Description:

Visit 1 Satisfaction questionnaire on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions.

Treatment:

Other: Satisfaction questionnaire