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OpenTrials
Completed

NCT Number: NCT05072470

Benefits of Assistive Listening Device for Speech Intelligibility

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
  • experienced hearing aid users
  • symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
  • good written and spoken English language skills
  • healthy outer ear as confirmed by otoscopy

Exclusion criteria

  • contradictions to medical device noted upon otoscopy
  • known hypersensitivity or allergy to materials of investigational device or comparator
  • inability to produce reliable test results
  • known psychological problems
  • self reported symptoms of dizziness or vertigo

Treatment and study plan

Roger microphone

Device

Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.

Phonak Audeo hearing aid

Device

Commercially available receiver-in-canal hearing aid

Primary outcomes

  1. Speech Intelligibility in Noise

    Time frame: Day 1 of a one day study

    The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Hearts for Hearing

Registry information

Official study title

Benefits of an Assistive Listening Device for Speech Intelligibility in Noise

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2021
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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