Preference Comparisons for Algorithms to Hear Speech

Not Applicable

Recruiting

• Conditions: Hearing Loss

• Registration Number: NCT05561335
• Lead Sponsor: Sonova AG

Brief Summary

Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.

Detailed Description

People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.

This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.

Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2023-03-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

• Including adults with sensorineural mild to moderate-severe hearing loss
• hearing aid experience (greater than 6 months)
• who are able to complete the task in English.
• Language: Can speak and understand English Fluently

Hearing loss within the fitting ranges of the investigational products.

• Healthy outer ear.
• Ability to understand instructions.
• Ability to describe listening experiences.
• Ability to fill out questionnaires.
• Informed consent as documented by signature.

Exclusion Criteria

• The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:

• Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
• Limited mobility and not able to attend to appointments or not able to go in a car.
• Reported symptoms of vertigo and dizziness by subject.
• Severe Tinnitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall preference for a specific microphone setting/configuration	20 minutes	Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')

Secondary Outcome Measures

Name	Time	Method
Rating of awareness of background noise	20 minutes	Scale from 0-100 with descriptors ('not at all' to 'extremely aware')
Rating of annoyance of artefacts	20 minutes	Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')
Rating of Listening effort	20 minutes	Scale from 1 - 7 with descriptors ('not at all' to 'very')

Trial Locations

Locations (1)

Western University; 🇨🇦 London, Ontario, Canada