Real World Perspectives on Advancements in Hearing Aid Technology

This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Audeo previous generation hearing aids; Device: Phonak Audeo Lumity hearing aids

Detailed Description

Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.

This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Phonak Audiology Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate sensorineural hearing loss
• Experienced hearing aid user
• Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
• Smartphone user for receiving study alerts

Exclusion Criteria:

• Cognitive impairment
• Not willing to wear hearing aid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants tested with comparator devices first, then Audeo Lumity devices; All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices.	Device: Phonak Audeo previous generation hearing aids; Receiver-in-canal (RIC) hearing aids with universal earpieces; Device: Phonak Audeo Lumity hearing aids; Receiver-in-canal (RIC) hearing aids with universal earpieces
Experimental: Participants who were tested with Audeo Lumity first, then comparator devices; All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices.	Device: Phonak Audeo previous generation hearing aids; Receiver-in-canal (RIC) hearing aids with universal earpieces; Device: Phonak Audeo Lumity hearing aids; Receiver-in-canal (RIC) hearing aids with universal earpieces

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech in Noise Test	A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.	Day 1 of study
Subjective Perception of Listening Effort	Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.	Day 1 of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Significant Other questionnaire	A subjective questionnaire that will obtain the participant's significant other perspective on the participant's performance with the study devices, in noisy situations. Each question is rated on a scale from -3 to +3, where a negative number indicates the significant other perceives the participant to be performing worse with study devices, and a positive number indicates the significant other perceives the participant to be performing better with study devices.	Day 1 of study, Day 14 of study

Collaborators and Investigators

• Sponsor: Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 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: SRF-2855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes