Trial Outcomes & Findings for In Field Performance of a Hearing Aid Transducer (NCT NCT04787055)

Results Overview

Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Three months after initial appointment

Results posted on

2023-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Receiver in the Canal Hearing Instrument 3 Month Group of subjects who will get the receiver in the canal hearing instrument and wear for three months.	Receiver in the Canal Hearing Instrument 6 Month Group of participants who will get the receiver in the canal hearing instrument and wear for six months.
Overall Study STARTED	18	17
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Receiver in the Canal Hearing Instrument 3 Month n=18 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period.	Receiver in the Canal Hearing Instrument 6 Month n=17 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 6 month period.	Total n=35 Participants Total of all reporting groups
Age, Continuous	73 years n=18 Participants	72 years n=17 Participants	72.5 years n=35 Participants
Sex: Female, Male Female	7 Participants n=18 Participants	6 Participants n=17 Participants	13 Participants n=35 Participants
Sex: Female, Male Male	11 Participants n=18 Participants	11 Participants n=17 Participants	22 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Three months after initial appointment

Population: Participants who answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" after 3 months of wearing devices.

Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Outcome measures

Outcome measures
Measure	Receiver in the Canal Hearing Instrument 3 Month n=15 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period.
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments	3.86 score on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: Six months after initial appointment

Population: Participants who wore device for six months and answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" at the end of the six months.

Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Outcome measures

Outcome measures
Measure	Receiver in the Canal Hearing Instrument 3 Month n=11 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period.
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments	2.73 score on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: Three months after initial appointment

Population: Participants who wore devices for three months and who answered the question at the end of the 3 months "How satisfied were you with the performance of the hearing aid when streaming?"

Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Outcome measures

Outcome measures
Measure	Receiver in the Canal Hearing Instrument 3 Month n=15 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media	4.67 score on a scale Interval 2.0 to 5.0

PRIMARY outcome

Timeframe: Six months after initial appointment

Population: Participants who wore devices for 6 months and who answered the question at the end of the 6 months "How satisfied were you with the performance of the hearing aid when streaming?"

Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.

Outcome measures

Outcome measures
Measure	Receiver in the Canal Hearing Instrument 3 Month n=11 Participants Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media	4.36 score on a scale Interval 4.0 to 5.0

Adverse Events

Receiver in the Canal Hearing Instrument 3 Month

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Receiver in the Canal Hearing Instrument 6 Month

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Receiver in the Canal Hearing Instrument 3 Month n=18 participants at risk Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months. Receiver-in-canal hearing instrument: Receiver-in-canal hearing instrument	Receiver in the Canal Hearing Instrument 6 Month n=17 participants at risk Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months. Receiver-in-canal hearing instrument: Receiver-in-canal hearing instrument
Renal and urinary disorders Unanticipated death	0.00% 0/18 • Three months for participants who were in the group assigned devices for three months, and six months for the participants who were in group assigned devices for six months.	5.9% 1/17 • Number of events 1 • Three months for participants who were in the group assigned devices for three months, and six months for the participants who were in group assigned devices for six months.

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

Sonova US Corporate Services, LLC

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place