Trial Outcomes & Findings for Investigations of Ear Tip Performance, Perceptions, and Experiences (NCT NCT05725824)

Last Updated: 2024-07-29

Results Overview

Evaluation of ear canal acoustics with participant wearing a hearing aid and earmold type (3d party control, in-house\_Resin, in-house\_PLA). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the earmold type is changed and recording is repeated until all ear mold material types have been tested for each individual. Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

15 minutes

Results posted on

2024-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	3rd Party Control, Then In-house PLA, Then In-house_RES In this arm, participants were first fit and tested with a 3rd party control, then in-house PLA, then in-house\_RES earmold	In-house_RES, Then 3rd Party Control, Then In-house PLA In this arm, participants were first fit and tested with a in-house\_RES, then 3rd party control, then a in-house\_PLA earmold	In-house PLA, Then In-house_RES, Then 3rd Party Control In this arm, participants were fit with a in-house PLA, then in-house\_RES, then 3rd party control earmold.
Overall Study STARTED	10	10	10
Overall Study COMPLETED	10	10	10
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigations of Ear Tip Performance, Perceptions, and Experiences

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Group n=30 Participants Crossover trial of 30 individuals with normal hearing
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized White/Non-hispanic	14 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Outcome measures

Outcome measures
Measure	3rd Party Control n=30 Participants Participants each wore and were tested with 3rd party control ear mold for 15 minutes.	In-house_RES n=30 Participants Participants each wore and were tested with study in-house\_RES ear mold for 15 minutes.	In-house_PLA n=30 Participants Participants each wore and were tested with study in-house\_PLA ear mold for 15 minutes.
Real Ear Measures REAG_2000s	61.23 dB SPL Standard Deviation 2.49	60.23 dB SPL Standard Deviation 2.01	60.5 dB SPL Standard Deviation 2.27
Real Ear Measures REAG_1000m	64.53 dB SPL Standard Deviation 2.61	66.5 dB SPL Standard Deviation 2.73	66.23 dB SPL Standard Deviation 2.65
Real Ear Measures REAG_500l	74.43 dB SPL Standard Deviation 2.01	75.4 dB SPL Standard Deviation 2.11	74.5 dB SPL Standard Deviation 2.00
Real Ear Measures REAG_1000l	70.83 dB SPL Standard Deviation 2.57	72.23 dB SPL Standard Deviation 3.17	71.8 dB SPL Standard Deviation 3.40

PRIMARY outcome

Timeframe: 2nd listening session appointment (15 minutes)

A questionnaire eliciting patient perception of physical comfort, quality of voice, and overall self-perceived satisfaction. Includes 12 items (5 point) that are scored on a 0 to 100, with 100 representing best possible function/rating

Outcome measures

Outcome measures
Measure	3rd Party Control n=30 Participants Participants each wore and were tested with 3rd party control ear mold for 15 minutes.	In-house_RES n=30 Participants Participants each wore and were tested with study in-house\_RES ear mold for 15 minutes.	In-house_PLA n=30 Participants Participants each wore and were tested with study in-house\_PLA ear mold for 15 minutes.
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire PerceptVoice	3.6 score on a scale Standard Deviation 0.97	3.77 score on a scale Standard Deviation 1.22	3.6 score on a scale Standard Deviation 1.22
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire NaturalSound	3.17 score on a scale Standard Deviation 1.02	3.43 score on a scale Standard Deviation 1.25	3.3 score on a scale Standard Deviation 1.12
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire PhysComfort	3.9 score on a scale Standard Deviation 0.97	4 score on a scale Standard Deviation 1.11	3.73 score on a scale Standard Deviation 1.05

PRIMARY outcome

Timeframe: Prior to 2nd listening session appointment (15 minutes)

Physical dimensions of each ear mold type (3rd party Control, in-house\_Resin, in-house\_PLA) were taken using digital calipers in millimeters prior to being worn by participants.

Outcome measures

Outcome measures
Measure	3rd Party Control n=30 Participants Participants each wore and were tested with 3rd party control ear mold for 15 minutes.	In-house_RES n=30 Participants Participants each wore and were tested with study in-house\_RES ear mold for 15 minutes.	In-house_PLA n=30 Participants Participants each wore and were tested with study in-house\_PLA ear mold for 15 minutes.
Physical Dimensions HeightTotal	27.19 millimeters Standard Deviation 2.01	27.73 millimeters Standard Deviation 1.92	27.39 millimeters Standard Deviation 1.85
Physical Dimensions WidthTotal	21.42 millimeters Standard Deviation 3.76	22.50 millimeters Standard Deviation 3.55	22.23 millimeters Standard Deviation 3.49
Physical Dimensions VentDiam	2.56 millimeters Standard Deviation 0.41	2.51 millimeters Standard Deviation 0.37	2.23 millimeters Standard Deviation 0.36
Physical Dimensions DepthTotal	15.25 millimeters Standard Deviation 1.66	13.88 millimeters Standard Deviation 2.26	13.65 millimeters Standard Deviation 1.86
Physical Dimensions Height_mEC	7.72 millimeters Standard Deviation 1.13	8.21 millimeters Standard Deviation 0.91	8.38 millimeters Standard Deviation 0.99

PRIMARY outcome

Timeframe: Prior to 2nd listening session appointment (15 minutes)

The total raw cost ($) for each ear mold type (3rd party\_control, in-house\_RES, and in-house\_PLA).

Outcome measures

Outcome measures
Measure	3rd Party Control n=30 Participants Participants each wore and were tested with 3rd party control ear mold for 15 minutes.	In-house_RES n=30 Participants Participants each wore and were tested with study in-house\_RES ear mold for 15 minutes.	In-house_PLA n=30 Participants Participants each wore and were tested with study in-house\_PLA ear mold for 15 minutes.
Production Variable	59.95 dollars ($) Standard Deviation 0.00	1.29 dollars ($) Standard Deviation 0.20	0.04 dollars ($) Standard Deviation 0.00

Adverse Events

3rd Party Control, Then In-house_PLA, Then In-house_Resin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

In-house_Resin, Then 3rd Party Control, Then In-house_PLA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

In-house_PLA, Then In-house_Resin, Then 3rd Party Control

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

Dr. Bryan Wong

University of Arizona

Phone: 5206268549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place