NCT05468918

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

July 18, 2022

Results QC Date

July 12, 2023

Last Update Submit

August 1, 2023

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Participants tested with comparator devices first, then Audeo Lumity devices

EXPERIMENTAL

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 aidsDevice: Phonak Audeo Lumity hearing aids

Participants who were tested with Audeo Lumity first, then comparator devices

EXPERIMENTAL

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 aidsDevice: Phonak Audeo Lumity hearing aids

Interventions

Phonak Audeo previous generation hearing aidsDEVICE

Receiver-in-canal (RIC) hearing aids with universal earpieces

Participants tested with comparator devices first, then Audeo Lumity devicesParticipants who were tested with Audeo Lumity first, then comparator devices
Phonak Audeo Lumity hearing aidsDEVICE

Receiver-in-canal (RIC) hearing aids with universal earpieces

Participants tested with comparator devices first, then Audeo Lumity devicesParticipants who were tested with Audeo Lumity first, then comparator devices

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Cognitive impairment
  • Not willing to wear hearing aid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Research
Organization
Sonova USCS
phonakaudiologyresearch@gmail.com
630-821-5000

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded as to which device they were wearing during the lab testing.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2022

First Posted

July 21, 2022

Study Start

July 18, 2022

Primary Completion

October 26, 2022

Study Completion

October 26, 2022

Last Updated

August 22, 2023

Results First Posted

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)