Hearing Loss
Conditions
Brief summary
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.
Interventions
DEVICEMDHearing smart hearing aid
air conduction hearing aid with app support
Sponsors
Central Michigan University
MDHearingAid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years old * At least one air conduction threshold above 15dB HL. * All air conduction thresholds must be under 60dB HL
Exclusion criteria
* Signs of outer or middle ear pathology * Greater than 60db HL hearing loss at any frequency.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 month | 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. |
| Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance. | 1 hour | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 36 |
| 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 | 35 |
| Total | 91 |
Baseline characteristics
| Characteristic | Clinical Study - Self Fit Group | Clinical Study - Professional Fit Group | Human Factors | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 15 Participants | 5 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 15 Participants | 55 Participants |
| Age, Continuous | 62 years | 58 years | 52 years | 52 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 36 Participants | 35 Participants | 20 Participants | 91 Participants |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 10 Participants | 49 Participants |
| Sex: Female, Male Male | 18 Participants | 14 Participants | 10 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 0 / 20 | 0 / 36 | 0 / 35 |
| serious Total, serious adverse events | 0 / 20 | 0 / 36 | 0 / 35 |
Outcome results
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| APHAB - Self Fit Group | Human Factors Study: Percentage of Participants Able to Use Hearing Aids Both With and Without Guidance. | 100 percentage of participants |
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.
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APHAB - Self Fit Group | 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. | 32 Participants |
| APHAB - Professional Fit Group | 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. | 32 Participants |
| SSQ 12 - Self Fit Group | 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. | 32 Participants |
| SSQ 12 - Professional Fit Group | 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. | 32 Participants |
| SSQ 12 Part B - Self Fit Group | 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. | 32 Participants |
| SSQ 12 Part B - Professional Fit Group | 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. | 32 Participants |