Recruiting

Observational Study

Sponsor:

Sonova AG

Code:

NCT05561335

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

hearing aid -novel program

hearing aid - standard program

Study Details

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.

Conditions

Hearing Loss

Study ID

NCT05561335

Start date

Mar 21, 2023

Status verified date

Sep, 2023

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

hearing aid -novel program

novel microphone configuration

hearing aid - standard program

standard microphone configuration

Primary outcome measure

  • Overall preference for a specific microphone setting/configuration [ Time Frame: 20 minutes ]

Central Contacts and Locations

Central contacts

Don Hayes, PhD

519 500 3618don.hayes@unitron.com

Locations

Western University

Recruiting

London, Ontario, Canada, N6G 1G9

Contacts

Paula Folkeard, AuD

519-661-2111folkeard@nca.uwo.ca

More Information

Sponsor

Sonova AG

Last update posted

Sep 7, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sonova AG on 2023-09-07.