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Completed

NCT Number: NCT05956808

Phonak Behind-The-Ear Quality Evaluation

Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

About this study

Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
  • 18+ years old
  • Good written and spoken English language skills
  • Able to fill in a questionnaire conscientiously
  • Experienced hearing aid user
  • Able to produce a reliable hearing test result
  • Able to describe listening impressions/experiences and the use of the hearing aids

Exclusion criteria

  • Not willing to test the hearing aids
  • Has auricle deformities that prevents secure placement of the hearing aids
  • Has limited mobility and is not able to attend the appointments
  • Not willing to wear the hearing aids for at least 8 hours per day
  • Known hypersensitivity or allergy with synthetic materials
  • Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
  • Hints of psychological problems
  • Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

Treatment and study plan

Phonak Naida BTE hearing aid

Device

Newest generation of ultra-power Phonak BTE hearing aids

Phonak Naida legacy BTE hearing aid

Device

Previous model/generation of the Naida BTE hearing aid

Primary outcomes

  1. Speech in Noise Test

    Time frame: Day 14 of the study

    Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.

  2. Subjective measure of listening effort

    Time frame: Day 14 of the study

    A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Aug 21, 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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