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Phonak Behind-The-Ear Quality Evaluation

Phonak Behind-The-Ear Quality Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05956808
Enrollment
7
Registered
2023-07-21
Start date
2023-07-17
Completion date
2023-08-16
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Sensorineural

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.

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.

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

Sponsors

Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will be blinded as to which hearing device they are wearing during lab testing.

Intervention model description

This investigation model is a cross-over design, randomized, and is single-blinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Speech in Noise TestDay 14 of the studySentences 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.
Subjective measure of listening effortDay 14 of the studyA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026