Preference Comparisons for Algorithms to Hear Speech

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: hearing aid -novel program; Device: hearing aid - standard program

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Don Hayes, PhD; Phone Number: 519 500 3618; Email: don.hayes@unitron.com

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G 1G9
      • Recruiting
      • Western University
      • Contact: Paula Folkeard, AuD; Phone Number: 88936 519-661-2111; Email: folkeard@nca.uwo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hearing Aid use for listening to speech in a common difficult situation; The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Western University
• Investigators: Principal Investigator: Susan Scollie, PhD, Western University (aka The University of Western Ontario)

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Estimated): October 31, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: 5251

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No