Preference Comparisons for Algorithms to Hear Speech

Hearing Loss Clinical Trial

Official title:

Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561335
• Other study ID #: 5251
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2023
• Source: Sonova AG
• Contact: Don Hayes, PhD
• Phone: 519 500 3618
• Email: don.hayes[@]unitron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• hearing aid -novel program
novel microphone configuration
• hearing aid - standard program
standard microphone configuration

Locations

Country	Name	City	State
Canada	Western University	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Western University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall preference for a specific microphone setting/configuration	Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')	20 minutes
Secondary	Rating of awareness of background noise	Scale from 0-100 with descriptors ('not at all' to 'extremely aware')	20 minutes
Secondary	Rating of Listening effort	Scale from 1 - 7 with descriptors ('not at all' to 'very')	20 minutes
Secondary	Rating of annoyance of artefacts	Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')	20 minutes