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Neuro 1 vs. Neuro 2 Sound Processors

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Oticon Medical

Status

Completed

Conditions

Cochlear Hearing Loss
Hearing Loss, Sensorineural

Treatments

Device: Neuro 1 & Neuro 2
Device: Neuro 2 & Neuro 1

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Neuro 2 Upgrade
Experimental group
Description:
Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested.
Treatment:
Device: Neuro 1 & Neuro 2
Neuro 1 Downgrade
Experimental group
Description:
Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested.
Treatment:
Device: Neuro 2 & Neuro 1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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