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The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 16 mild-to-moderate sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, have 2 appointments of 1-2 hours including a fitting procedure with real-ear measurements and some standard speech tests and undergo two 2-weeks home trials (with questionnaires).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of Study Device followed by Own devices | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid Signia Pure C&G 7IX | Device | Receiver in Canal (RIC) hearing aid, M Receiver |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oldenburg Sentence Test | 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. | Estimated Time Frame 2 weeks (Test conducted at second lab session). |
| Measure | Description | Time Frame |
|---|---|---|
| Freiburger Monosyllabic Speech Test | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Vormann, PhD | Hörzentrum Oldenburg gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hörzentrum Oldenburg gGmbH | Oldenburg | 26129 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Field Test 1 (2 Weeks) Study Devices |
| |||||||||||||
| Field Test 2 (2 Weeks) Own Devices |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | within subject design: compare Pure C&G 7IX to subjects' own hearing aids. Baseline measures are the same for all study participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oldenburg Sentence Test | 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. | Posted | Mean | Standard Deviation | dB | Estimated Time Frame 2 weeks (Test conducted at second lab session). |
|
Adverse event data were collected for each participant during the course of the study for an average time period of 4 weeks, starting with the first lab session and ending with the end of the second field test.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | While Wearing Study Devices | Subjects wore the study devices for 2 weeks during first field test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Veronika Littmann | WSAUDAS | +4991313080 | Veronika.littmann@wsa.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2024 | Jun 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Own Hearing Aid | Device | subjects' own hearing aids, any brand, any model |
|
| Estimated Time Frame 2 weeks (Test conducted at second lab session). |
| Match-to-Target | 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. | 1 day (Fitting procedure with real-ear measurements is done at first lab session) |
| Speech, Spatial and Qualities of Hearing Questionnaire (SSQ) | 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. | 2 weeks |
| International Outcome Inventory for Hearing Aids (IOI-HA) | 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"). | 2 weeks |
| Satisfaction Questionnaire | 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. | 2 weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| mild to moderate Hearing Impairment | Count of Participants | 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
| OG001 | Results Unaided | Speech test without hearing aids |
| OG002 | Results With Own Devices | own devices are the subjects' own hearing aids, they can be any brand, any model |
|
|
|
| Secondary | Freiburger Monosyllabic Speech Test | 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. | Posted | Mean | Standard Deviation | Percent Correct | Estimated Time Frame 2 weeks (Test conducted at second lab session). |
|
|
|
| Secondary | Match-to-Target | 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. | Posted | Mean | Standard Deviation | dB | 1 day (Fitting procedure with real-ear measurements is done at first lab session) |
|
|
|
| Secondary | Speech, Spatial and Qualities of Hearing Questionnaire (SSQ) | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | International Outcome Inventory for Hearing Aids (IOI-HA) | 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"). | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | Satisfaction Questionnaire | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | While Wearing Own Devices | Subjects wore their own devices for 2 weeks during second field test | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Deviation from Target @ 2000 Hz |
|
| Deviation from Target @ 4000 Hz |
|
| Quality of Hearing |
|
| Naturalness |
|
| Conversation with one person |
|
| Comfort with loud sounds |
|