FindTrial
Sign In

Investigations of Ear Tip Performance, Perceptions, and Experiences

Novel Technology Adoption in the Audiology Clinic: Investigations of Ear Tip Performance, Perceptions, and Experiences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05725824
Acronym
IETPPE
Enrollment
30
Registered
2023-02-13
Start date
2023-07-30
Completion date
2024-01-17
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Aids

Keywords

earmold, hearing aid

Brief summary

Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.

Interventions

DEVICEBTE hearing aid with compatible earmolds

Hearing aids will be fit with three different types of customized earmolds. They will only wear each earmold group for the duration of the test (total = \ 2.5 hours). Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. A short washout period will follow completion of testing with ear earmold group.

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal hearing thresholds (\<25 dB HL) at octave frequencies from 250-8000Hz. * Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally. * English as primary spoken language.

Exclusion criteria

* history of extensive or current outer or middle ear pathology. * history of extensive outer or middle ear surgery. * history of neurological or cognitive disorder.

Design outcomes

Primary

MeasureTime frameDescription
Real Ear Measures15 minutesEvaluation 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.
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire2nd 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
Physical DimensionsPrior 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.
Production VariablePrior 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Overall Group
Crossover trial of 30 individuals with normal hearing
30
Total30

Baseline characteristics

CharacteristicOverall Group
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants
Race/Ethnicity, Customized
Asian
2 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants
Race/Ethnicity, Customized
Hispanic/Latino
7 Participants
Race/Ethnicity, Customized
More than one race
4 Participants
Race/Ethnicity, Customized
White/Non-hispanic
14 Participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 300 / 30
other
Total, other adverse events
0 / 300 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 300 / 30

Outcome results

Primary

Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire

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

Time frame: 2nd listening session appointment (15 minutes)

ArmMeasureGroupValue (MEAN)Dispersion
3rd Party ControlOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnaireNaturalSound3.17 score on a scaleStandard Deviation 1.02
3rd Party ControlOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePerceptVoice3.6 score on a scaleStandard Deviation 0.97
3rd Party ControlOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePhysComfort3.9 score on a scaleStandard Deviation 0.97
In-house_RESOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnaireNaturalSound3.43 score on a scaleStandard Deviation 1.25
In-house_RESOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePerceptVoice3.77 score on a scaleStandard Deviation 1.22
In-house_RESOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePhysComfort4 score on a scaleStandard Deviation 1.11
In-house_PLAOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePerceptVoice3.6 score on a scaleStandard Deviation 1.22
In-house_PLAOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnairePhysComfort3.73 score on a scaleStandard Deviation 1.05
In-house_PLAOuter Effectiveness of Auditory Rehabilitation (EAR) QuestionnaireNaturalSound3.3 score on a scaleStandard Deviation 1.12
p-value: <0.05Repeated Measure Analysis of Variance
Primary

Physical Dimensions

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
3rd Party ControlPhysical DimensionsHeight_mEC7.72 millimetersStandard Deviation 1.13
3rd Party ControlPhysical DimensionsDepthTotal15.25 millimetersStandard Deviation 1.66
3rd Party ControlPhysical DimensionsHeightTotal27.19 millimetersStandard Deviation 2.01
3rd Party ControlPhysical DimensionsWidthTotal21.42 millimetersStandard Deviation 3.76
3rd Party ControlPhysical DimensionsVentDiam2.56 millimetersStandard Deviation 0.41
In-house_RESPhysical DimensionsDepthTotal13.88 millimetersStandard Deviation 2.26
In-house_RESPhysical DimensionsHeightTotal27.73 millimetersStandard Deviation 1.92
In-house_RESPhysical DimensionsWidthTotal22.50 millimetersStandard Deviation 3.55
In-house_RESPhysical DimensionsHeight_mEC8.21 millimetersStandard Deviation 0.91
In-house_RESPhysical DimensionsVentDiam2.51 millimetersStandard Deviation 0.37
In-house_PLAPhysical DimensionsVentDiam2.23 millimetersStandard Deviation 0.36
In-house_PLAPhysical DimensionsHeight_mEC8.38 millimetersStandard Deviation 0.99
In-house_PLAPhysical DimensionsHeightTotal27.39 millimetersStandard Deviation 1.85
In-house_PLAPhysical DimensionsDepthTotal13.65 millimetersStandard Deviation 1.86
In-house_PLAPhysical DimensionsWidthTotal22.23 millimetersStandard Deviation 3.49
p-value: <0.05Repeated Measure Analysis of Variance
Primary

Production Variable

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

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

ArmMeasureValue (MEAN)Dispersion
3rd Party ControlProduction Variable59.95 dollars ($)Standard Deviation 0
In-house_RESProduction Variable1.29 dollars ($)Standard Deviation 0.2
In-house_PLAProduction Variable0.04 dollars ($)Standard Deviation 0
p-value: <0.05Repeated Measure Analysis of Variance
Primary

Real Ear Measures

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.

Time frame: 15 minutes

ArmMeasureGroupValue (MEAN)Dispersion
3rd Party ControlReal Ear MeasuresREAG_2000s61.23 dB SPLStandard Deviation 2.49
3rd Party ControlReal Ear MeasuresREAG_1000m64.53 dB SPLStandard Deviation 2.61
3rd Party ControlReal Ear MeasuresREAG_500l74.43 dB SPLStandard Deviation 2.01
3rd Party ControlReal Ear MeasuresREAG_1000l70.83 dB SPLStandard Deviation 2.57
In-house_RESReal Ear MeasuresREAG_1000l72.23 dB SPLStandard Deviation 3.17
In-house_RESReal Ear MeasuresREAG_2000s60.23 dB SPLStandard Deviation 2.01
In-house_RESReal Ear MeasuresREAG_500l75.4 dB SPLStandard Deviation 2.11
In-house_RESReal Ear MeasuresREAG_1000m66.5 dB SPLStandard Deviation 2.73
In-house_PLAReal Ear MeasuresREAG_1000l71.8 dB SPLStandard Deviation 3.4
In-house_PLAReal Ear MeasuresREAG_1000m66.23 dB SPLStandard Deviation 2.65
In-house_PLAReal Ear MeasuresREAG_500l74.5 dB SPLStandard Deviation 2
In-house_PLAReal Ear MeasuresREAG_2000s60.5 dB SPLStandard Deviation 2.27
p-value: <0.05Repeated Measure Analysis of Variance

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026