Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

NCT05150964 | Completed Results FDA Device

• 1 other identifier: SRF-379
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (6)

• Speech Reception Threshold

  A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.

  Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)

• Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.

  Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.

  Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

• Multi-word Recognition at 40 dB SPL and 70 dB SPL

  Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.

  Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)

• Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.

  A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.

  Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

• Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.

  A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.

  Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

• Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula

  Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

  2nd appointment (day 14 of study)

Study Arms (1)

Experimental

EXPERIMENTAL

One group will be fit with commercially available hearing aids that will have different program settings

Device: Phonak Audeo hearing aid

Interventions

Phonak Audeo hearing aid DEVICE

receiver in the canal devices with custom earmolds

Experimental

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
• Must use oral mode of communication
• must speak English

Sponsors & Collaborators

• Sonova AG: lead
• Arizona State University: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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: Director of Clinical Research
• Organization: Sonova USCS

phonakaudiologyresearch@gmail.com

630-821-5000

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: December 9, 2021
• Study Start: June 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: May 29, 2022
• Last Updated: May 19, 2023
• Results First Posted: May 19, 2023

Record last verified: 2023-05

Locations

US (1)