Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

Sensorineural Hearing Loss Clinical Trial

Official title:

Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03288753
• Other study ID #: PIC_14
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: January 11, 2019

Study information

• Verified date: March 2023
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 11, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Other:
• Satisfaction questionnaire
Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.

Behavioral:
• Speech intelligibility in quiet
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 correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
• Speech intelligibility in noise
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 correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
• VRB (Vocale Rapide dans le Bruit)
Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). 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. 3 lists are presented. Speech signals are presented at 60 dB SPL.

Locations

Country	Name	City	State
France	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 Necker-Enfants Malades	Paris
France	Hôpital Pitié Salpêtrière - APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction questionnaire	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.	15 minutes
Secondary	Speech comprehension in quiet	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.	15 mins
Secondary	Speech comprehension in Noise	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.	15 mins
Secondary	French Quick Sin	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.	5 mins