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Completed

NCT Number: NCT05072457

Benefit of Assistive Listening Device for Lateralization

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.

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Key information

Conditions

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

Age range

18 year–90 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

  • Experienced hearing aid users, age 18 or older
  • Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
  • Good understanding of the English language
  • Health outer ear as confirmed by otoscopy
  • Informed consent as documented by signature

Exclusion criteria

  • Contraindications to the medical device noted upon otoscopy
  • Known hypersensitivity or allergies to materials of the investigations device or comparator
  • Inability to produce reliable test results
  • Known psychological problems
  • Self reported symptoms of vertigo or dizziness

Treatment and study plan

Roger On microphone

Device

Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Roger Select microphone

Device

Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Primary outcomes

  1. Lateralization Hearing Ability

    Time frame: Day 1 of 1 day study

    Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)

  2. Spatial Hearing Ability

    Time frame: Day 1 of 1 day study

    Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Hearts for Hearing

Registry information

Official study title

Benefit of Assistive Listening Device for Lateralization and Spatial Hearing

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Jun 15, 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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