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| Name | Class |
|---|---|
| Central Michigan University | OTHER |
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Hearing aids are commonly used to help people with hearing loss hear better in daily listening environments. MDHearing Smart hearing aids are designed to use the MDHearing app to adjust hearing aids to each individual's hearing loss. This study intends to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve good aided benefit, which will be compared to those fitted by audiology professionals. This study includes three components: human factor study, self-fit study, and professional-fit study. The information obtained will be useful for both audiology professionals and people with impaired hearing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Factors | Other | The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss. |
|
| Clinical Study | Other | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDHearing smart hearing aid | Device | air conduction hearing aid with app support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale. | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation. | 1 month |
| Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance. | Subjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed. This group was separate from the Self Fit group and the Professional Group. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunfang Zheng, Sc.D. CCC-A | Central Michigan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Michigan University | Mount Pleasant | Michigan | 48859 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Factors | The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss. MDHearing smart hearing aid: air conduction hearing aid with app support |
| FG001 | Clinical Study - Self Fit Group | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit. MDHearing smart hearing aid: air conduction hearing aid with app support |
| FG002 | Clinical Study - Professional Fit Group | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. MDHearing smart hearing aid: air conduction hearing aid with app support |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Factors | The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss. MDHearing smart hearing aid: air conduction hearing aid with app support |
| BG001 | Clinical Study - Self Fit Group |
| 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 | Number of Participants With Improvement at 1 Month as Measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12) Scale. | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech Spatial Qualities 12 (SSQ 12). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation. | Posted | Count of Participants | Participants | 1 month |
|
Adverse events were collected during the time of the study. One hour for the Human Factors portion of the study and thirty days for the Clinical Trials portion of the study.
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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 | Human Factors | The purpose of the human factor study was to verify the feasibility of self-fitting MDHearing Smart hearing aid by listeners with a mild to moderate sensorineural hearing loss. MDHearing smart hearing aid: air conduction hearing aid with app support |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandra Porps | MDHearing | 7346572209 | slp@mdhearingaid.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2020 | Mar 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2022 | Mar 31, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit. MDHearing smart hearing aid: air conduction hearing aid with app support |
| BG002 | Clinical Study - Professional Fit Group | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. MDHearing smart hearing aid: air conduction hearing aid with app support |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| 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 | Count of Participants | Participants |
|
| OG001 | APHAB - Professional Fit Group | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Abbreviated Profile of Hearing Aid Benefit (APHAB). The lowest possible score on the APHAB is 1% with the highest score being 99%. A higher score indicates improvement. |
| OG002 | SSQ 12 - Self Fit Group | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. |
| OG003 | SSQ 12 - Professional Fit Group | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). On the SSQ, the scores range from 0 to 10 with a higher score indicating hearing perfectly in that situation. |
| OG004 | SSQ 12 Part B - Self Fit Group | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation. |
| OG005 | SSQ 12 Part B - Professional Fit Group | Comparison of aided benefit between the self-fit group and the professional fit group as measured by the Speech Spatial Qualities 12 (SSQ 12). For the SSQ Part B, the scores range from -5 to +5 with a higher score indicating improved hearing for that situation. |
|
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| Primary | Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance. | Subjects are able to use the hearing aids while using the app and manuals as guidance. Ease of use will be self reported by the subjects as to whether the task was able to be completed without guidance, able to be completed with guidance from the manual, or unable to be completed. Participants self-reported their comfort level with hearing aids and with technology in general. Participants sat with a researcher to note if tasks were able to be completed without guidance, with guidance from the manual, or unable to be completed. This group was separate from the Self Fit group and the Professional Group. | Posted | Number | percentage of participants | 1 hour |
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|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Clinical Study - Self-fit Group | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The self fit group intended to show whether the MDHearing Smart hearing aids can be fitted by each user reliably and if each user can use the MDHearing app on their smartphone or tablet to make adjustments to achieve a good aided benefit. MDHearing smart hearing aid: air conduction hearing aid with app support | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | Clinical Study - Professional-fit Group | The clinical study included two groups of subjects (self-fit and professional-fit groups) with the main purpose to compare the fitting outcomes between the two fitting groups. The professional-fit group aimed to show whether the MDHearing Smart hearing aids can be fitted by audiology professional on each user reliably and if each user can benefit from using the MDHearing smart hearing aids. MDHearing smart hearing aid: air conduction hearing aid with app support | 0 | 35 | 0 | 35 | 0 | 35 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|