Benefits of Assistive Listening Device for Speech Intelligibility

Hearing Loss Clinical Trial

Official title:

Benefits of an Assistive Listening Device for Speech Intelligibility in Noise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072470
• Other study ID #: SRF-70
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: December 13, 2021

Study information

• Verified date: August 2021
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)

• experienced hearing aid users

• symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)

• good written and spoken English language skills

• healthy outer ear as confirmed by otoscopy

Exclusion Criteria:

• contradictions to medical device noted upon otoscopy

• known hypersensitivity or allergy to materials of investigational device or comparator

• inability to produce reliable test results

• known psychological problems

• self reported symptoms of dizziness or vertigo

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Roger microphone
Commercially available transmitter microphone which sends distant speech signals to a receiver that is attached/embedded into hearing aids.
• Phonak Audeo hearing aid
Commercially available receiver-in-canal hearing aid

Locations

Country	Name	City	State
United States	Hearts for Hearing	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Hearts for Hearing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Intelligibility in Noise	The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.	Day 1 of a one day study