Trial Outcomes & Findings for Post-market Study to Capture Information Regarding Performance of Lyric2 (NCT NCT01861704)

Results Overview

Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

177 participants

Primary outcome timeframe

Following device removal at the same appointment (Up to 24 hours after removal)

Results posted on

2014-05-19

Participant Flow

Patients are fitted according to their ear size and experience level. Patients with a different experience level for each ear are only counted once.

Participant milestones

Participant milestones
Measure	Lyric Silver Lyric device Lyric: Extended wear hearing instrument	Lyric2 Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument
Overall Study STARTED	70	107
Overall Study COMPLETED	67	104
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-market Study to Capture Information Regarding Performance of Lyric2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lyric n=70 Participants Silver Lyric device Lyric: Extended wear hearing instrument	Lyric2 n=107 Participants Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument	Total n=177 Participants Total of all reporting groups
Age, Customized <=18 years of age	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized >18 years of age	70 participants n=5 Participants	107 participants n=7 Participants	177 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	35 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	72 Participants n=7 Participants	129 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	107 participants n=7 Participants	177 participants n=5 Participants

PRIMARY outcome

Timeframe: Following device removal at the same appointment (Up to 24 hours after removal)

Population: Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument

Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.

Outcome measures

Outcome measures
Measure	Lyric n=65 Experienced ears Silver Lyric device Lyric: Extended wear hearing instrument Only experienced ears counted	Lyric2 n=61 Experienced ears Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument Only experienced ears counted
Immediate Refit Upon Device Removal	78 percentage of ears Interval 68.0 to 86.0	93 percentage of ears Interval 86.0 to 98.0

SECONDARY outcome

Timeframe: During useful lifespan of device

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During useful lifespan of device

Outcome measures

Outcome data not reported

Adverse Events

Lyric

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Lyric2

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lyric n=70 participants at risk Silver Lyric device Lyric: Extended wear hearing instrument	Lyric2 n=107 participants at risk Lyric2 (Barracuda) device Lyric: Extended wear hearing instrument
Ear and labyrinth disorders Sound Quality -> Fine tuning	1.4% 1/70 • Number of events 1	0.00% 0/107
Ear and labyrinth disorders Acoustic Feedback -> Removal	1.4% 1/70 • Number of events 1	0.93% 1/107 • Number of events 1
Ear and labyrinth disorders Discomfort / Pain -> Removal	1.4% 1/70 • Number of events 1	1.9% 2/107 • Number of events 2
Ear and labyrinth disorders Handling -> Removal	0.00% 0/70	0.93% 1/107 • Number of events 1
Ear and labyrinth disorders Sound Quality -> Removal	0.00% 0/70	1.9% 2/107 • Number of events 2
Ear and labyrinth disorders Handling -> Fine tuning	1.4% 1/70 • Number of events 1	0.00% 0/107

Additional Information

Tanya Arbogast, Study Principal Investigator

InSound Medical, Newark, California

Phone: 510-792-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place