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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16

Sonova logo

Sonova

Status

Completed

Conditions

Hearing Loss
Normal Hearing

Treatments

Device: Hearing Aid with BF
Device: Hearing Aid without NR and BF
Device: Hearing Aid with NR

Study type

Interventional

Funder types

Industry

Identifiers

NCT03578471
Sonova2018_16

Details and patient eligibility

About

An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Enrollment

44 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

Exclusion criteria

  • Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Massively limited dexterity
  • Known psychological problems
  • Known central hearing disorders

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

44 participants in 3 patient groups

Hearing Aid without NR and BF
Active Comparator group
Description:
Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
Treatment:
Device: Hearing Aid without NR and BF
Hearing Aid with NR
Experimental group
Description:
Hearing Aid with Noise Reduction (NR) enabled.
Treatment:
Device: Hearing Aid with NR
Hearing Aid with BF
Experimental group
Description:
Hearing Aid with beam forming (BF) enabled.
Treatment:
Device: Hearing Aid with BF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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