Trial Outcomes & Findings for Clinical Validation of the Lexie Lumen Hearing Aid (NCT NCT05337748)

Results Overview

The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24 item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).The final score is determined by subtracting the aided average from the unaided average, keeping in mind that the score indicates how frequently the individual experiences communication difficulty. Therefore a higher score indicates a poorer outcome. (Minimum score 1% to a maximum score of 99%).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

68 participants

Primary outcome timeframe

Change from baseline assessment to final assessment after 30 day field trial use.

Results posted on

2025-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing test. The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms.	Control: Lexie Professional Test and Fit Group (Lexie PTF) The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Overall Study STARTED	35	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing test. The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms.	Control: Lexie Professional Test and Fit Group (Lexie PTF) The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Overall Study Withdrawal by Subject	1	0
Overall Study Death	1	0

Baseline Characteristics

Clinical Validation of the Lexie Lumen Hearing Aid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing test. The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.	Total n=64 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	65.3 years STANDARD_DEVIATION 14.9 • n=7 Participants	63.7 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment South Africa	32 participants n=5 Participants	32 participants n=7 Participants	64 participants n=5 Participants
Pure tone audiometry	38.4 Decibel Hearing Level (dB HL) STANDARD_DEVIATION 11.7 • n=5 Participants	41.8 Decibel Hearing Level (dB HL) STANDARD_DEVIATION 13.6 • n=7 Participants	40.1 Decibel Hearing Level (dB HL) STANDARD_DEVIATION 25.3 • n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline assessment to final assessment after 30 day field trial use.

Population: Originally, 68 participants met the inclusion criteria for the study. In the Lexie STF group, 1 participant was lost to follow up and one discontinued the intervention. For analysis, one participant was excluded from this group due to an incorrect fitting resulting from researcher error. In the Lexie PTF group, 33 participants met the inclusion criteria, but one was excluded from analysis at the end of the study to not being matched to target and experiencing significant device feedback.

The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24 item self-assessment inventory in which patients report the amount of trouble they experience hearing and communicating in noise in different everyday listening environments. Benefit is calculated by comparing the patient's reported difficulty in the unaided condition with their amount of difficulty when using amplification. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV).The final score is determined by subtracting the aided average from the unaided average, keeping in mind that the score indicates how frequently the individual experiences communication difficulty. Therefore a higher score indicates a poorer outcome. (Minimum score 1% to a maximum score of 99%).

Outcome measures

Outcome measures
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. Participants will self-perform an in-situ hearing test and prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Abbreviated Profile of Hearing Aid Benefit (APHAB)	30.1 score on a scale (1-99) Standard Deviation 21.9	21.4 score on a scale (1-99) Standard Deviation 21.5

SECONDARY outcome

Timeframe: Final assessment after 30 day field use

Population: Originally, 68 participants met the inclusion criteria for the study. In the Lexie STF group, 1 participant was lost to follow up and one discontinued the intervention. For analysis, one participant was excluded from this group due to an incorrect fitting resulting from researcher error. In the Lexie PTF group, 33 participants met the inclusion criteria, but one was excluded from analysis at the end of the study to not being matched to target and experiencing significant device feedback.

IOI HA is a seven item questionnaire designed to evaluate effectiveness of hearing aid treatment. The responses of the items are assigned a value of 1 to 5, with higher scores indicating a more favorable outcome. The total score is calculated as the sum of all the subscales. Minimum score for the total score is 7 and maximum score 35.

Outcome measures

Outcome measures
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. Participants will self-perform an in-situ hearing test and prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
International Outcome Inventory for Hearing Aids (IOI-HA)	31 score on a scale (7-35) Interval 30.0 to 33.0	31 score on a scale (7-35) Interval 28.0 to 34.0

SECONDARY outcome

Timeframe: Baseline and benefit at the end of 30 day field use

Population: Originally,68 participants met the inclusion criteria for the study. In the Lexie STF group, 1 participant was lost to follow up and one discontinued the intervention. For analysis, one participant was excluded from this group due to an incorrect fitting resulting from researcher error. In the Lexie PTF group, 33 participants met the inclusion criteria, but one was excluded from analysis at the end of the study to not being matched to target and experiencing significant device feedback.

The QuickSIN measures a persons ability to accurately hear speech in noise by determining a signal-to-noise ratio loss. A list of six sentences with five key words per sentence is presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult). To score, the number of correctly repeated words from each of the six sentences are counted. The SNR loss is calculated by subtracting the total number of correct words from 25.5. Three lists are averaged to obtain an average SNR score. The SNRs used are: 25, 20, 15, 10, 5 and 0, encompassing normal to severely impaired performance in noise. Benefit scores are calculated as unaided (without hearing aids) -aided (with hearing aids) score. Benefit scores at 30 days are presented in the data table.

Outcome measures

Outcome measures
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. Participants will self-perform an in-situ hearing test and prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
QuickSIN Speech in Noise Test	1.6 Decibel Signal to Noise Ratio (dB SNR) Standard Deviation 4.4	3.5 Decibel Signal to Noise Ratio (dB SNR) Standard Deviation 4.5

SECONDARY outcome

Timeframe: Baseline unaided test and aided fitting final assessment after 30 day field use

Population: 68 participants met the inclusion criteria for the study. In the Lexie STF group, 1 participant was lost to follow up and one discontinued the intervention. For analysis, one participant was excluded from this group due to an incorrect fitting resulting from researcher error. In the Lexie PTF group, 33 participants met the inclusion criteria, but one was excluded from analysis at the end of the study to not being matched to target and experiencing significant device feedback.

The DIN measure primarily the auditory, or bottom-up, speech recognition abilities in noise. The test determines a speech reception threshold by presenting spoken digit triplets (e.g., 3-4-7) in speech weighted background masking noise. Twenty three digits are presented adaptively at different signal to noise ratios, based on correct or incorrect recognition of the digits. The speech reception threshold is determined by averaging the signal to noise ratios of the last 19 digit triplets. Benefit scores are calculated as unaided baseline- aided at 30 days after field trial use. Benefit scores are presented in the data table.

Outcome measures

Outcome measures
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. Participants will self-perform an in-situ hearing test and prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Digits-in-noise Test (DIN)	.50 Decibel Signal to Noise Ratio (dB SNR) Standard Deviation 2.6	0.13 Decibel Signal to Noise Ratio (dB SNR) Standard Deviation 4.7

SECONDARY outcome

Timeframe: Final assessment after 30 day field use

Population: 68 participants met the inclusion criteria for the study. In the Lexie STF group, 1 participant was lost to follow up and one discontinued the intervention. For analysis, one participant was excluded from this group due to an incorrect fitting resulting from researcher error. In the Lexie PTF group, 33 participants met the inclusion criteria, but one was excluded from analysis at the end of the study to not being matched to target and experiencing significant device feedback.

Real Ear Measurements (REM) involves placing a fine probe microphone into the ear canal to measure the sound at the eardrum. The hearing aid will be inserted in the ear alongside the probe microphone to measure the amplification effect within the patients ear taking into account the patient ear acoustics. Adjustments to the hearing aid can be made and measurement to best match the prescription target. The specific REM measure used will be Live Speech Mapping, which assesses the hearing aid output using realistic speech presented via a loudspeaker with the hearing aid in its normal mode of operation. The outcome measure of Live Speech Mapping is the decibel sound pressure level (dB SPL) across a range of frequencies (250Hz to 4000Hz), calculated as the difference from the NAL-NL2 target (i.e. NAL-NL2 target- measured dB SPL).

Outcome measures

Outcome measures
Measure	Experimental : Lexie Self Test and Fit Group (Lexie STF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids. Participants will self-perform an in-situ hearing test and prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds. Participants will be fitted according to the customized, Lexie optimal fit prescribed gain setting. The optimal settings include the original gain and compression requirements that NAL-NL2 suggests for various audiograms. No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application. Lexie Self Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with a slimtube and dome. The hearing aids will be accompanied and operated using the Lexie smartphone application. Participants will self-perform an in-situ hearing check (pure tones presented via the hearing aids). The prescriptive gain of the hearing aids will be programmed and applied automatically using the obtained in-situ hearing thresholds No additional band equalizer or compression adjustments are added. After a specified period of time, participants will be able to self-adjust the hearing aids using the smartphone application.	Control: Lexie Professional Test and Fit Group (Lexie PTF) n=32 Participants The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids. Lexie Professional Test and Fit Group: The intervention offered is a hearing aid fitting with Lexie Lumen hearing aids coupled with slimtube and dome. Hearing aids will be fitted by a certified audiologist according to a gold-standard prescriptive formula (NAL-NL2) using a clinically obtained diagnostic pure tone audiogram. Participants will have access to the smartphone application, but the settings will be limited with only options to change the volume of the hearing aids.
Live Speech Mapping Using Real Ear Measurements (REM) 250Hz	0.6 dB SPL Standard Deviation 2.5	3.0 dB SPL Standard Deviation 4.1
Live Speech Mapping Using Real Ear Measurements (REM) 500Hz	1.3 dB SPL Standard Deviation 3.1	2.7 dB SPL Standard Deviation 4.0
Live Speech Mapping Using Real Ear Measurements (REM) 1000 Hz	4.7 dB SPL Standard Deviation 6.2	4.3 dB SPL Standard Deviation 6.4
Live Speech Mapping Using Real Ear Measurements (REM) 2000 Hz	-2.7 dB SPL Standard Deviation 6.8	0.6 dB SPL Standard Deviation 6.5
Live Speech Mapping Using Real Ear Measurements (REM) 4000 Hz	6.9 dB SPL Standard Deviation 7.6	4.4 dB SPL Standard Deviation 6.4

Adverse Events

Experimental : Lexie Self Test and Fit Group (Lexie STF)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Control: Lexie Professional Test and Fit Group (Lexie PTF)

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

Professor De Wet Swanepoel

University of Pretoria

Phone: +27827824009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place