Phonak Behind-The-Ear Quality Evaluation

Hearing Loss, Sensorineural Clinical Trial

Official title:

Phonak Behind-The-Ear Quality Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05956808
• Other study ID #: SRF-12872
• Status: Completed
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Phonak Naida BTE hearing aid
Newest generation of ultra-power Phonak BTE hearing aids
• Phonak Naida legacy BTE hearing aid
Previous model/generation of the Naida BTE hearing aid

Locations

Country	Name	City	State
United States	Phonak Audiology Research Center	Aurora	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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