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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04

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Sonova

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Hearing Aid with frequency lowering enabled
Device: Hearing Aid without frequency lowering enabled

Study type

Interventional

Funder types

Industry

Identifiers

NCT03992963
Sonova2019_04

Details and patient eligibility

About

Participants will take part in both a passive and active emotion recognition task: (1) passively listening to semantically-neutral sentences with emotional prosody, and (2) actively listening and subsequently categorizing emotional sentences and sounds. Participants are seated and instructed to stare at a fixation cross while the stimulus is played. During this study, non-invasive physiological measurements of pupil dilation will be recorded from the participants. Using this paradigm we will be assessing the effect of frequency lowering on emotion recognition. The study takes the form of a partly three factorial design (passive task x frequency lowering x acclimatization). Participants also perform a two factor design (active task x frequency lowering). Each participant performs two passive tests (20 minutes long each) with frequency lowering on and off, and a four week acclimatization period in-between. Participants perform one active listening task after the acclimatization period with frequency lowering on and off.

Enrollment

8 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
  • Minimum 1 year hearing aid experience
  • Moderate-Severe (N3-N5) hearing loss or Normal Hearing

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
  • 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

8 participants in 2 patient groups

Hearing Aid without frequency lowering enabled
Active Comparator group
Treatment:
Device: Hearing Aid without frequency lowering enabled
Hearing Aid with frequency lowering enabled
Experimental group
Treatment:
Device: Hearing Aid with frequency lowering enabled

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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