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Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03288753
Enrollment
98
Registered
2017-09-20
Start date
2017-10-02
Completion date
2019-01-11
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss, Cochlear Hearing Loss

Keywords

Cochlear implant

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).

Interventions

Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.

BEHAVIORALSpeech 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.

BEHAVIORALSpeech 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.

BEHAVIORALVRB (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.

Sponsors

Oticon Medical
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction questionnaire15 minutesThe 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

MeasureTime frameDescription
Speech comprehension in quiet15 minsThe 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 Noise15 minsThe 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 Sin5 minsThis 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026