Eargo : Clinically Standard Verification and Validation of OTC Self-Fitting Hearing Aids

Clinically Standard Verification and Validation of OTC Self-Fitting Hearing Aids

INTRODUCTION

In 2022, the US Food and Drug Administration issued final regulations to establish a category of over-the-counter (OTC) hearing aids. As these regulations are new and technology is rapidly changing, users' objective and subjective outcomes with these devices are not yet well understood.

Lauren Pasquesi*, Joyce Rosenthal*, Tong Sheng*,

Andrew Johnson*, Travis Allyn*, Jayaganesh Swaminathan*

Eargo, Inc., San Jose, CA, US *

RESULTS

Sound Match Process

User instructed to		App performs ambient		App guides users		In-situ thresholds obtained		App calculates custom gain		Custom settings
insert left and right		noise check to ensure		through threshold		using modified Hughson-		settings based on hearing		programmed to
devices		a quiet environment		measurement		Westlake procedure		assessment results		devices
Clinical Audiogram vs. In-App Assessment	Real-Ear Aided Response compared to NAL-NL2

DISCUSSION

Study results show effective objective and subjective verification and validation of a new OTC device using standard clinical measures.

This is evidenced by:

• Minimal average	deviation (<6dB) of in-
app threshold	to clinical audiogram

The main goal of this study was to assess the objective fitting and subjective effectiveness of then in-development (Eargo SE) self-fitting hearing aids using standard clinical measures.

METHODS

• 24 subjects with self-perceived hearing loss

were recruited for this study.

• Subjects followed the manufacturer's in-app

instructions for self-fitting (Sound Match),

Average - Right Ear

		Frequency (Hz)
	500	1000	2000	3000	4000
	0
	10
	20
	30
(dBHL)	40
50
Threshold	60
70
80
	90

Average - Left Ear

		Frequency (Hz)
	500	1000	2000	3000	4000
	0
	10
	20
	30
(dBHL)	40
50
Threshold	60
70
80
	90

	threshold
• Minimal	average deviation	of	REAR
	values from NAL-NL2 moderate targets
	(<6dB)
•	Notable improvement across all APHAB
	domains	post-study	(except	for
	aversiveness, as expected)
•	Great	comparative		subjective
	performance to regular users of WDRC
	hearing aids across all domains as
	measured by APHAB

including a self-administered hearing

assessment in which the hearing aid acts as

the transducer.

100

110

120

In-App Assessment Clinical Audiogram

100

110

120

In-App Assessment Clinical Audiogram

• Great subjective effectiveness of hearing

aid fit across varied listening situations as

measured by COSI

• A traditional audiogram was completed in a

sound-treated booth by an experienced

audiologist, who was blinded to the results of

the subject's self-fitting assessment results.

• The clinical audiograms were compared to

the self-administered hearing assessment

results.

• Objective fit was assessed by using

APHAB Results

				Pre-Study				Post-Study
		←Peak to the left is better	Peak to the right is worse→
		Global					Ease of Communication
	45%							45%
Subjects	40%					Subjects	40%
35%					35%
30%					30%
of	25%					of	25%
Percentage	20%					Percentage	20%
15%					15%
10%					10%

Figure above - REAR in response to moderate ISTS speech and NAL-NL2 moderate targets. Average device response shown after the Sound Match process, without adjustments, and compared to targets generated from the gold standard booth audiogram. Average target error from 500-4000 Hz. ranges from 0.7-5.7 dB for moderate ISTS input signal.

COSI Results

COSI: Rate your ability to hear well in the following situations while using these

hearing aids

• Improved subjective effectiveness of

hearing aid fit across varied listening

situations when comparing the unaided and aided conditions as measured by

COSI

Taken together, this data reconfirms objectively and subjectively that new-to- market self-fitting OTC hearing aids are able to appropriately compensate for mild-to-

Audioscan Verifit2® to compare measured

real ear aided responses (REAR) to NAL-

NL2 targets. Target generation was based

on subject's booth thresholds.

• Real-world sound quality and overall

hearing-aid satisfaction were validated with

APHAB and COSI questionnaires after 4-5

weeks of device wear in-field.

PARTICIPANTS

Table 1 - Participant Demographics

	5%			5%
	0%			0%
	0-910-1920-2930-3940-4950-5960-6970-7980-8990-99		0-910-1920-2930-3940-4950-5960-6970-7980-8990-99
		Percentage of Problems			Percentage of Problems
		Background Noise			Reverberation
	45%			45%
Subjects	40%		Subjects	40%
35%		35%
30%		30%
of	25%		of	25%
Percentage	20%		Percentage	20%
15%		15%
10%		10%
5%		5%

Conversation with 1 or 2 in quiet

Conversation with 1 or 2 in noise

Conversation with a group in quiet

Conversation with a group in noise

Television/ radio at a normal volume

Listening to a person talking on the phone

Soft sounds

The sound of your own voice

Listening to music (i.e., live or from speakers)

4%		39%
7%	29%
11%	29%
11%	43%
7%	50%
18%	25%
4% 4%	39%
4%	4%	14%
4%		32%

57%

54%

61%

39%

43%

57%

54%

79%

64%

11%

7%

moderate hearing loss.

FUTURE DIRECTIONS

• These results may aid in future research

and development of self-fitting hearing aid

strategies as they continue to be

developed from principles of clinical

audiology and hearing science.

• Efforts should be made to evaluate future

Characteristic	Value
Age (years)

0%		0%
0-910-1920-2930-3940-4950-5960-6970-7980-8990-99	0-910-1920-2930-3940-4950-5960-6970-7980-8990-99
	Percentage of Problems		Percentage of Problems

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

products using varied clinical verification

and validation methods to continue to

Mean (SD)	74.4 (7.2)
Median	75
Range	60-87

	Aversiveness
45%		•
40%

APHAB scores are reported in percentage of problems, therefore a lower score is a better score

COSI: When using these hearing aids, how much better are you hearing in the

following situations compared to without hearing aids?

ensure similar clinical efficacy to

traditional hearing aids.

Gender, n (%)
Female	8 (33.3%)
Male	16 (66.7%)
In-study days per week use
0-2 days	0 (0%)
3-4 days	2 (8.3%)
5-7 days	22 (91.7%)
In-study hours per day use
1-4 hours	1 (4.2%)
4-8 hours	9 (37.5%)
8+ hours	14 (58.3%)
High-Frequency Pure Tone Average (1, 2, 3, 4 kHz), (dB)
Mean (SD)	47.4 (9.0)

Subjects	35%		•
30%
of	25%
Percentage	20%

15%

10%

5%

0%

0-910-1920-2930-3940-4950-5960-6970-7980-8990-99

Percentage of Problems

Using APHAB normative data, on average Eargo SE users are performing better than…

•71.2% of hearing aid users with ease of communication

•70.5% of hearing aid users with reverberation

All APHAB conditions improved compared to pre- study condition, except aversiveness, which is expected

APHAB Score Comparisons

	60
Problemsof	50
40
Percentage	30
20

10

Conversation with 1 or 2 in quiet

Conversation with 1 or 2 in noise

Conversation with a group in quiet

Conversation with a group in noise

Television/ radio at a normal volume

Listening to a person talking on the phone

Soft sounds

The sound of your own voice

Listening to music (i.e., live or from speakers)

4%	18%
7%	11%
4%	14%
4%	18%
7%
11%	11%
4%

7% 4% 7%

7%

7%

32%

43%

32%

43%

43%

54%

43%

50%

43%

46%

39%

50%

36%

50%

25%

54%

36%

43%

CONTACT

Lauren Pasquesi, Au.D., F-AAA [e-mail]

2665 N. First St. Ste. 300 San Jose, CA 95134 www.eargo.com

Median	47.5
Range	31.3-66.3

•68.4% of hearing aid users with background noise

•59.45% of hearing aid users with aversiveness

0

Global

EC

RV

BN

AV

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%