Optimizing Soft Speech Recognition in Children With Hearing Loss

NCT05299892 | Completed Results FDA Device

• 1 other identifier: 458
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable to provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (1)

• Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists

  One word list of 25 words is presented at 50 dB (quiet conditions) through a front speaker. The percent correctly repeated words are calculated and a higher score indicates better speech perception. The participants completed this task without hearing aids. Data was collected on both age groups, but analysis was completed only on the entire group as a whole. Age effects were not tested.

  Day 1 of 1 day study

Secondary Outcomes (1)

• Subjective Ratings of Speech Enhancer

  Day 1 of 1 day study

Study Arms (1)

Children with Hearing Loss

EXPERIMENTAL

Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in unaided and aided condition.

Device: Phonak Audeo P or Naida P hearing aid

Interventions

Phonak Audeo P or Naida P hearing aid DEVICE

Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"

Children with Hearing Loss

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• native English speakers who communicate verbally
• no known speech language disorders, cognitive or learning issues
• experienced hearing aid users (\> 6 months use)
• "full-time" hearing aid users (i.e., wear on a daily basis)
• CNC word scores of 30% or better at 50dBA in quiet with SE "off"

You may not qualify if:

• new hearing aid users
• inconsistent hearing aid users
• \<4 years or \>12 years of age
• non-native English speaker who communicates verbally
• known cognitive/ learning issues or speech language disorder
• CNC word scores \< 30% correct presented at 50dBA in quiet with SE "off"

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; Hearing Loss, Bilateral

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: Sara Neumann, AuD
• Organization: Hearts For Hearing

sara.neumann@heartsforhearing.org

405-548-4300

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be "blind" as to whether the Speech Enhancer feature is activated or deactivated.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group of participants will be assessed unaided and aided with Phonak Audeo P or Phonak Naida P hearing aids with Speech Enhancer "off", "on at moderate", and "on at strong" settings.

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 29, 2022
• Study Start: March 21, 2022
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: December 14, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-11

Locations

US (1)