Benefit of Assistive Listening Device for Lateralization

NCT05072457 | Completed Results FDA Device

• 1 other identifier: SRF-387
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.

Conditions

Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (2)

• Lateralization Hearing Ability

  Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)

  Day 1 of 1 day study

• Spatial Hearing Ability

  Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)

  Day 1 of 1 day study

Study Arms (1)

Experimental

EXPERIMENTAL

All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.

Device: Roger On microphone; Device: Roger Select microphone

Interventions

Roger On microphone DEVICE

Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Experimental

Roger Select microphone DEVICE

Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Experimental

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experienced hearing aid users, age 18 or older
• Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
• Good understanding of the English language
• Health outer ear as confirmed by otoscopy
• Informed consent as documented by signature

You may not qualify if:

• Contraindications to the medical device noted upon otoscopy
• Known hypersensitivity or allergies to materials of the investigations device or comparator
• Inability to produce reliable test results
• Known psychological problems
• Self reported symptoms of vertigo or dizziness

Sponsors & Collaborators

• Sonova AG: lead
• Hearts for Hearing: collaborator

Study Sites (1)

Hearts for Hearing

Oklahoma City, Oklahoma, 73120, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lead Investigator
• Organization: Hearts for Hearing

phonakaudiologyresearch@gmail.com

405-548-4335

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 11, 2021
• Study Start: October 18, 2021
• Primary Completion: December 13, 2021
• Study Completion: July 2, 2022
• Last Updated: June 15, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-05

Locations

US (1)