Phonak Behind-The-Ear Quality Evaluation

NCT ID: NCT05956808

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2023-08-16

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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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.

Group Type EXPERIMENTAL

Phonak Naida BTE hearing aid

Intervention Type DEVICE

Newest generation of ultra-power Phonak BTE hearing aids

Phonak Naida legacy BTE hearing aid

Intervention Type DEVICE

Previous model/generation of the Naida BTE hearing aid

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.

Group Type EXPERIMENTAL

Phonak Naida BTE hearing aid

Intervention Type DEVICE

Newest generation of ultra-power Phonak BTE hearing aids

Phonak Naida legacy BTE hearing aid

Intervention Type DEVICE

Previous model/generation of the Naida BTE hearing aid

Interventions

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Phonak Naida BTE hearing aid

Newest generation of ultra-power Phonak BTE hearing aids

Intervention Type DEVICE

Phonak Naida legacy BTE hearing aid

Previous model/generation of the Naida BTE hearing aid

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phonak Audiology Research Center

Aurora, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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SRF-12872

Identifier Type: -

Identifier Source: org_study_id

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