Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

Not Applicable

Completed

• Conditions: Sensorineural Hearing Loss; Cochlear Hearing Loss

• Registration Number: NCT03288753
• Lead Sponsor: Oticon Medical

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 Timeline

• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Study Start: 2017-10-02
• Primary Completion: 2019-01-11
• Study Completion: 2019-01-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Satisfaction questionnaire	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 Outcome Measures

Name	Time	Method
Speech comprehension in quiet	15 mins	The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
Speech comprehension in Noise	15 mins	The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
French Quick Sin	5 mins	This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB.

Trial Locations

Locations (9)

Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Roger Salengro; 🇫🇷 Lille, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHRU de Nancy Hôpital central; 🇫🇷 Nancy, France

CHU de Nantes Hôtel-Dieu; 🇫🇷 Nantes, France

CHU Nice - Institut Universitaire de la Face et du Cou; 🇫🇷 Nice, France

Hôpitaux Pédiatriques de Nice CHU-Lenval; 🇫🇷 Nice, France

Hôpital Pitié Salpêtrière - APHP; 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France