Clinical trial NCT05561335: Preference Comparisons for Algorithms to Hear Speech
Official title: Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Western University
First posted: 2022-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall preference for a specific microphone setting/configuration
timeFrame: 20 minutes
Secondary outcomes:
measure: Rating of awareness of background noise
timeFrame: 20 minutes
measure: Rating of Listening effort
timeFrame: 20 minutes
measure: Rating of annoyance of artefacts
timeFrame: 20 minutes
Other outcomes:
Locations:
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University (aka The University of Western Ontario)
name: Susan Scollie, PhD
role: PRINCIPAL_INVESTIGATOR
References: