NCT05956808

Brief Summary

Subjective listening effort and objective speech intelligibility will be evaluated with a new generation of a Phonak BTE (Behind-The-Ear) hearing aid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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 14, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

July 14, 2023

Last Update Submit

August 18, 2023

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (2)

  • Speech in Noise Test

    Sentences are presented to either the left or right side of the participant's head through a speaker that is 1 meter away. Background noise is presented through the remaining seven speakers that are arranged in a circular pattern around the participant. The sentences are presented at varying levels which may be both louder and softer than the fixed level of noise. The SNR50 is the Signal to Noise Ratio (SNR) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3 dB louder than the noise. Lower SNR50 scores indicate better performance.

    Day 14 of the study

  • Subjective measure of listening effort

    A rating scale will be given to the participants following the Speech in Noise Test in which they will rate their perceived listening effort during the test.

    Day 14 of the study

Study Arms (2)

New BTE hearing aid first, then legacy BTE hearing aid

EXPERIMENTAL

All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid.

Device: Phonak Naida BTE hearing aidDevice: Phonak Naida legacy BTE hearing aid

Legacy BTE hearing aid first, then new BTE hearing aid

EXPERIMENTAL

All participants who complete speech intelligibility testing and subjective listening effort ratings with both devices, first with the new hearing aid, and then with the legacy hearing aid.

Device: Phonak Naida BTE hearing aidDevice: Phonak Naida legacy BTE hearing aid

Interventions

Phonak Naida BTE hearing aidDEVICE

Newest generation of ultra-power Phonak BTE hearing aids

Legacy BTE hearing aid first, then new BTE hearing aidNew BTE hearing aid first, then legacy BTE hearing aid
Phonak Naida legacy BTE hearing aidDEVICE

Previous model/generation of the Naida BTE hearing aid

Legacy BTE hearing aid first, then new BTE hearing aidNew BTE hearing aid first, then legacy BTE hearing aid

Eligibility Criteria

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

You may qualify if:

  • Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
  • + years old
  • Good written and spoken English language skills
  • Able to fill in a questionnaire conscientiously
  • Experienced hearing aid user
  • Able to produce a reliable hearing test result
  • Able to describe listening impressions/experiences and the use of the hearing aids

You may not qualify if:

  • Not willing to test the hearing aids
  • Has auricle deformities that prevents secure placement of the hearing aids
  • Has limited mobility and is not able to attend the appointments
  • Not willing to wear the hearing aids for at least 8 hours per day
  • Known hypersensitivity or allergy with synthetic materials
  • Self reports symptoms of vertigo, dizziness, fluctuating hearing loss
  • Hints of psychological problems
  • Suffers from acute tinnitus in either one or both ears (occurrence less than 3 months)

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, Sensorineural

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded as to which hearing device they are wearing during lab testing.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This investigation model is a cross-over design, randomized, and is single-blinded.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 21, 2023

Study Start

July 17, 2023

Primary Completion

August 16, 2023

Study Completion

August 16, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared outside of Sonova research departments.

Locations

US(1)