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Neuro 1 vs. Neuro 2 Sound Processors

Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03756337
Enrollment
20
Registered
2018-11-28
Start date
2019-11-01
Completion date
2020-01-10
Last updated
2021-10-20

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

Conditions

Cochlear Hearing Loss, Hearing Loss, Sensorineural

Keywords

cochlear implant, sound processor, upgrade

Brief summary

This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

Detailed description

The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.

Interventions

DEVICENeuro 1 & Neuro 2

participant common fitting map used for tests

DEVICENeuro 2 & Neuro 1

participant common fitting map used for tests

Sponsors

Oticon Medical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* written informed consent * primary implantation * subject having participated to previous Neuro 1 sound processor study in Canada * fluent in English, including reading and writing.

Exclusion criteria

* psychologically unsuitable * unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device * non compliant with all investigational requirements.

Design outcomes

Primary

MeasureTime frameDescription
speech recognition in quietDay 1Hearing In Noise Test

Secondary

MeasureTime frameDescription
speech recognition in noiseDay 1Hearing In Noise Test
pure tone thresholdDay 1from 250Hz to 8kHz

Countries

Canada

Outcome results

None listed

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