Trial Outcomes & Findings for Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO (NCT NCT06700512)
NCT ID: NCT06700512
Last Updated: 2025-08-08
Results Overview
The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
COMPLETED
NA
20 participants
Estimated Time Frame 2 weeks (Test conducted at second lab session).
2025-08-08
Participant Flow
Participant milestones
| Measure |
Evaluation of Study Device Followed by Own Devices
within subject design: Subjects wear the study devices for 2 weeks followed by wearing their own hearing aids for 2 weeks. Study devices are fitted as per standard-of-care.
Study Hearing Aid Signia Pure C\&G 7IX: Receiver in Canal (RIC) hearing aid, M Receiver
Own Hearing Aid: subjects' own hearing aids, any brand, any model
|
|---|---|
|
Field Test 1 (2 Weeks) Study Devices
STARTED
|
20
|
|
Field Test 1 (2 Weeks) Study Devices
COMPLETED
|
20
|
|
Field Test 1 (2 Weeks) Study Devices
NOT COMPLETED
|
0
|
|
Field Test 2 (2 Weeks) Own Devices
STARTED
|
20
|
|
Field Test 2 (2 Weeks) Own Devices
COMPLETED
|
20
|
|
Field Test 2 (2 Weeks) Own Devices
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Participants
n=20 Participants
within subject design: compare Pure C\&G 7IX to subjects' own hearing aids. Baseline measures are the same for all study participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=20 Participants
|
|
mild to moderate Hearing Impairment
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Estimated Time Frame 2 weeks (Test conducted at second lab session).The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
n=20 Participants
Speech test without hearing aids
|
Results With Own Devices
n=20 Participants
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
Oldenburg Sentence Test
|
-6.6 dB
Standard Deviation 4.5
|
-1.1 dB
Standard Deviation 7.5
|
-3.5 dB
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Estimated Time Frame 2 weeks (Test conducted at second lab session).To investigate speech intelligibility (SI) performance for speech at 65dB in a quiet listening situation, the Freiburger monosyllabic speech test is used which is still the gold standard for Hearing Care Professionals (HCPs) in Germany. Results are reported in Percent correct data. Minimum is 0%, maximum is 100% with higher values meaning better speech understanding.
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
n=20 Participants
Speech test without hearing aids
|
Results With Own Devices
n=20 Participants
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
Freiburger Monosyllabic Speech Test
|
75.1 Percent Correct
Standard Deviation 12.3
|
31.5 Percent Correct
Standard Deviation 20.1
|
68.6 Percent Correct
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 1 day (Fitting procedure with real-ear measurements is done at first lab session)Investigate how close the study hearing aids fitted and fine-tuned with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements. Absolute deviations were calculated at specific frequencies ranging from 250 Hz to 4 kHz. Unit of measure is dB SPL. Minimum Value is 0 (i.e. measured value and target value identical), no maximum value. Higher values mean greater deviation from target.
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
Speech test without hearing aids
|
Results With Own Devices
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
Match-to-Target
Deviation from Target @ 250 Hz
|
3.3 dB
Standard Deviation 4.0
|
—
|
—
|
|
Match-to-Target
Deviation from Target @ 500 Hz
|
1.6 dB
Standard Deviation 1.7
|
—
|
—
|
|
Match-to-Target
Deviation from Target @ 1000 Hz
|
1.2 dB
Standard Deviation 1.4
|
—
|
—
|
|
Match-to-Target
Deviation from Target @ 2000 Hz
|
1.6 dB
Standard Deviation 1.9
|
—
|
—
|
|
Match-to-Target
Deviation from Target @ 4000 Hz
|
1.5 dB
Standard Deviation 1.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The aim of the SSQ questionnaire was to compare the performance/benefit of the study hearing aids to the subjects' own devices. As the unaided ratings would have been the same for both arms, they would have cancelled out by comparing the two interventions and thus it was considered as not necessary to collect the unaided responses.
A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, quality of hearing perceived in real-life. Questions are answered on a scale from 0 to 10, higher scores mean better outcomes. The responses to the individual questions are grouped for the subsections (speech, spatial, quality) by calculating the means.
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
n=20 Participants
Speech test without hearing aids
|
Results With Own Devices
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Speech Perception
|
6.2 score on a scale
Standard Deviation 2.3
|
5.8 score on a scale
Standard Deviation 1.9
|
—
|
|
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Sound Localization
|
6.9 score on a scale
Standard Deviation 2.4
|
6.2 score on a scale
Standard Deviation 1.6
|
—
|
|
Speech, Spatial and Qualities of Hearing Questionnaire (SSQ)
Quality of Hearing
|
7.9 score on a scale
Standard Deviation 1.3
|
7.3 score on a scale
Standard Deviation 1.7
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The IOI-HA was developed to measure outcomes in audiological rehabilitation using Hearing Aids and is not designed for the unaided condition. For this reason only the two interventional arms are included for this outcome measure.
Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are given on a scale from 1 - 5. Here, the mean of questions 2 -7 is reported. Higher values represent better outcomes. Question 1 was on wearing time, which is not considered a rating of effectiveness and was therefore excluded from the mean and will be reported separately. Fpr wearing times higher values represent longer wearing time (maximum 5 equals "more than 8 hours a day").
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
n=20 Participants
Speech test without hearing aids
|
Results With Own Devices
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
Mean effectiveness ratings
|
3.6 score on a scale
Standard Deviation 1.0
|
3.8 score on a scale
Standard Deviation 0.7
|
—
|
|
International Outcome Inventory for Hearing Aids (IOI-HA)
Wearing Time
|
5.0 score on a scale
Standard Deviation 0.2
|
4.9 score on a scale
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The satisfaction questionnaire was developed to measure satisfaction with hearing aids and not designed for the unaided condition. For this reason data was only collected for the two interventional arms.
Investigate satisfaction in real-life for different aspects such as sound quality, naturalness of sound, conversation with one person and overall satisfaction. Each aspect was assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied) The overall satisfaction and sound quality overall were individual questions and are not the combination of different situations/aspects. These questions were also assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied). Higher values represent better outcomes.
Outcome measures
| Measure |
Results With Study Device
n=20 Participants
within subject design: compare speech understanding with study device to speech understanding with subjects' own hearing aids or no hearing aids (unaided).
Study devices are Signia Pure C\&G 7IX Receiver-in-the-canal hearing aids with M-Receiver
|
Results Unaided
n=20 Participants
Speech test without hearing aids
|
Results With Own Devices
own devices are the subjects' own hearing aids, they can be any brand, any model
|
|---|---|---|---|
|
Satisfaction Questionnaire
Sound quality overall
|
5.4 score on a scale
Standard Deviation 1.3
|
5.5 score on a scale
Standard Deviation 1.2
|
—
|
|
Satisfaction Questionnaire
Overall Satisfaction
|
5.1 score on a scale
Standard Deviation 1.5
|
5.1 score on a scale
Standard Deviation 1.5
|
—
|
|
Satisfaction Questionnaire
Naturalness
|
5.4 score on a scale
Standard Deviation 1.4
|
5.2 score on a scale
Standard Deviation 1.5
|
—
|
|
Satisfaction Questionnaire
Conversation with one person
|
5.4 score on a scale
Standard Deviation 1.6
|
5.6 score on a scale
Standard Deviation 1.4
|
—
|
|
Satisfaction Questionnaire
Comfort with loud sounds
|
5.0 score on a scale
Standard Deviation 1.3
|
4.5 score on a scale
Standard Deviation 1.4
|
—
|
Adverse Events
While Wearing Study Devices
While Wearing Own Devices
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60