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CompletedNCT05956808Updated Aug 21, 2023

Phonak Behind-The-Ear Quality Evaluation

An interventional study of Phonak Naida BTE hearing aid and Phonak Naida legacy BTE hearing aid in Hearing Loss, Sensorineural, sponsored by Sonova AG. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Sonova AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Speech intelligibility performance will be measured with a new generation BTE hearing aid and compared to a legacy hearing aid in adults with severe to profound hearing loss.

02

Conditions studied

  • Hearing Loss, Sensorineural
03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 764 interventional studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

Sonova AG is the lead sponsor of 82 studies on the registry; 6 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 17 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Severe to profound hearing loss (4 frequency Pure Tone Average 65-94 dB)
  • 18+ 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    New BTE hearing aid first, then legacy BTE hearing aid

    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 aid · Device: Phonak Naida legacy BTE hearing aid

  • Experimental
    Legacy BTE hearing aid first, then new BTE hearing aid

    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 aid · Device: Phonak Naida legacy BTE hearing aid

Interventions

  • DevicePhonak Naida BTE hearing aid

    Newest generation of ultra-power Phonak BTE hearing aids

  • DevicePhonak Naida legacy BTE hearing aid

    Previous model/generation of the Naida BTE hearing aid

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 14 of the study

  2. 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.

    Time frame: Day 14 of the study

07

Study locations

1 site
  • Phonak Audiology Research Center
    Aurora, Illinois 60504, United States
08

References and documents

Individual participant data

Plan to share: No — No individual participant data will be shared outside of Sonova research departments.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05956808
Lead sponsor
Sonova AG
Responsible party
Sponsor
First posted
Jul 21, 2023
Start date
Jul 17, 2023
Primary completion
Aug 16, 2023
Completion
Aug 16, 2023
Last update
Aug 21, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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