Trial Outcomes & Findings for Optimizing Soft Speech Recognition in Children With Hearing Loss (NCT NCT05299892)

Last Updated: 2023-12-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Day 1 of 1 day study

Results posted on

2023-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Hearing Impaired Users Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and complete all testing requirements (unaided, aided with SE off, aided with SE on moderate, and aided with SE on strong).
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Hearing Impaired Users Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and complete all testing requirements (unaided, aided with SE off, aided with SE on moderate, and aided with SE on strong).
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children With Hearing Loss, Age 5-12 n=36 Participants Participants age 5-12 with hearing loss who will be fit with study hearing aids and tested on speech perception in all four required conditions: Unaided, Aided with SE off, Aided with SE moderate, and Aided with SE strong. Phonak Audeo P or Naida P hearing aid: Commercially available hearing aid that has access to speech enhancer feature settings "off", "moderate" and "strong"
Age, Continuous	9 years n=36 Participants
Sex: Female, Male Female	16 Participants n=36 Participants
Sex: Female, Male Male	20 Participants n=36 Participants
Region of Enrollment United States	36 participants n=36 Participants

PRIMARY outcome

Timeframe: Day 1 of 1 day study

Population: Hearing impaired participants who completed all required testing conditions: 1) word recognition unaided, 2)word recognition at 40 dB input with SE off, 3) word recognition at 40 dB input with SE on moderate setting, 4) word recognition at 40 dB input with SE on strong setting, 5) word recognition at 50 dB input with SE off, 6) word recognition with at 50 dB input with SE on moderate setting, and 7) word recognition with 50 dB input with SE on strong setting.

Outcome measures

Outcome measures
Measure	Hearing Impaired Children Age 5-12 n=33 Participants Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and tested in all four required conditions: unaided condition at 50 dB, and aided condition with SE off, on at moderate, and on at strong at 40 and 50 dB.
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct unaided, in quiet (50 dBA)	6.06 percentage of correctly repeated words Standard Deviation 9.73
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct aided with SE off, in quiet ( 40 dBA)	53.7 percentage of correctly repeated words Standard Deviation 13.02
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct, aided with SE moderate, in quiet (40 dBA)	66.61 percentage of correctly repeated words Standard Deviation 11.92
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct, aided with SE strong, in quiet (40 dBA)	69.7 percentage of correctly repeated words Standard Deviation 12
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct, aided SE off, in quiet (50 dBA)	74.7 percentage of correctly repeated words Standard Deviation 9.1
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct, aided SE moderate, in quiet (50 dBA)	81.76 percentage of correctly repeated words Standard Deviation 6.78
Speech Recognition in Quiet Using CNC (Consonant-Nucleus-Consonant) Word Lists Percent words correct, aided SE strong, in quiet (50 dBA)	83.76 percentage of correctly repeated words Standard Deviation 6.87

SECONDARY outcome

Timeframe: Day 1 of 1 day study

Population: All participants who completed the testing requirements and were able to provide answers to all three questions: 1) Which sounds better? 2) Which is more comfortable? and 3) Which do you prefer? Data was collected on both age groups, but was analysis was completed only on entire group as a whole. Age effects were not analyzed.

Participants will listen to a sound sample of looped sentences overlaid with low-level transient noise with the Speech Enhancer at different settings (off, moderate, strong) and rate their preference. An A/B comparison will be used to compare Speech Enhancer Off vs. Speech Enhancer Moderate, and Speech Enhancer Off vs. Speech Enhancer Strong. Participants answered three questions: 1) Which sounds better?, 2) Which is more comfortable?, and 3) Which do you prefer? Results will be reported as qualitative data and no statistical analysis will take place.

Outcome measures

Outcome measures
Measure	Hearing Impaired Children Age 5-12 n=32 Participants Hearing impaired children, age 5 -12 years who are fit with either Audeo P or Naida P and tested in all four required conditions: unaided condition at 50 dB, and aided condition with SE off, on at moderate, and on at strong at 40 and 50 dB.
Subjective Ratings of Speech Enhancer SE Moderate sounds better than SE Off	10 Participants
Subjective Ratings of Speech Enhancer SE Moderate sounds the same as SE Off	16 Participants
Subjective Ratings of Speech Enhancer SE Off sounds better than SE Moderate	6 Participants
Subjective Ratings of Speech Enhancer SE Moderate is more comfortable than SE Off	6 Participants
Subjective Ratings of Speech Enhancer SE Moderate is the same comfort as SE Off	14 Participants
Subjective Ratings of Speech Enhancer SE Off is more comfortable than SE Moderate	12 Participants
Subjective Ratings of Speech Enhancer Prefer SE Moderate to SE Off	12 Participants
Subjective Ratings of Speech Enhancer Prefer both SE Off and SE Moderate the same	12 Participants
Subjective Ratings of Speech Enhancer Prefer SE Off to SE Moderate	8 Participants
Subjective Ratings of Speech Enhancer SE Strong sounds better than SE Off	15 Participants
Subjective Ratings of Speech Enhancer SE Strong sounds the same as SE Off	11 Participants
Subjective Ratings of Speech Enhancer SE Off sounds better than SE Strong	5 Participants
Subjective Ratings of Speech Enhancer SE Strong is more comfortable than SE Off	8 Participants
Subjective Ratings of Speech Enhancer SE Strong is the same comfort as SE Off	17 Participants
Subjective Ratings of Speech Enhancer SE Off is more comfortable than SE Strong	6 Participants
Subjective Ratings of Speech Enhancer Prefer SE Strong to SE Off	16 Participants
Subjective Ratings of Speech Enhancer Prefer both SE Strong and SE Off the same	9 Participants
Subjective Ratings of Speech Enhancer Prefer SE Off to SE Strong	6 Participants

Adverse Events

Children With Hearing Loss

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara Neumann, AuD

Hearts For Hearing

Phone: 405-548-4300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place