Clinical trial NCT03288753: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Cochlear Hearing Loss
Keywords: Cochlear implant
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Satisfaction questionnaire
timeFrame: 15 minutes
Secondary outcomes:
measure: Speech comprehension in quiet
timeFrame: 15 mins
measure: Speech comprehension in Noise
timeFrame: 15 mins
measure: French Quick Sin
timeFrame: 5 mins
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Nancy
country: France
facility: CHRU de Nancy Hôpital central
city: Nantes
country: France
facility: CHU de Nantes Hôtel-Dieu
city: Nice
country: France
facility: CHU Nice - Institut Universitaire de la Face et du Cou
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière - APHP
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Hôpital Roger Salengro CHRU de Lille
name: Christophe Vincent, MD, PROF
role: PRINCIPAL_INVESTIGATOR
References: