Hearing Loss
Conditions
Keywords
Conductive Hearing Loss, Mixed Hearing Loss
Brief summary
The purpose of this clinical investigation is to test a new Sound Processor (SP) to compare hearing performance of the new Sound Processor with unaided hearing and Baha 5 SP in adult subjects and to investigate which device (new Sound Processor versus Baha 5) the subjects prefer.
Interventions
DEVICENew Sound Processor
The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
Sponsors
Statistiska Konsultgruppen
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adult subject (18-\<70 years of age) * At least 12 months experience from using a Baha Connect system (percutaneous Baha) * Subject with a conductive or mild to moderate mixed hearing loss. that would benefit from improved hearing from bone conduction device as judged by the research audiologist * Willing and able to provide written informed consent
Exclusion criteria
* Signs of infection around the implant site * Unable to follow investigational procedures * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator * Investigator site personnel directly affiliated with this investigation and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. * Cochlear employees * Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | Day 0, day 7 and day 14 | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding |
| Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF | Day 14 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | Day 0 and day 7 | Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz\] |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | Day 0 and day 7 | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words. |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Day 14 | Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips. |
| Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Day 7 and day 14 | Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor. |
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | Day 14 | Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort. |
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | Day 0, day 7 and day 14 | Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz\] |
| Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | Day 0, day 7 and day 14 | Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words |
| Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Day 14 | Participant rating Yes or No for internal noise after listening to sound clips. |
| Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise | Day 0 and day 7 | Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding |
Countries
Sweden
Participant flow
Recruitment details
16 participants were recruited in one centre from 23 September 2020 to 27 November 2020.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Crossover, participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Entire Study Population | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 12 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 16 Participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
Primary
Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB Sound Pressure Level (SPL) and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Time frame: Day 0, day 7 and day 14
Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 6 Max | Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | -3.7 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 2.75 |
| Unaided | Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise | 4.8 db SNR (decibel Speech in Noise Ratio) | Standard Deviation 6.55 |
Primary
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
Time frame: Day 14
Population: Participants received Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baha 6 Max | Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF | 13 Participants |
| Unaided | Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF | 3 Participants |
Secondary
Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Diary completed by the participant with following topics: daily use of the sound processor (hours), change of battery, switch to their own sound processor.
Time frame: Day 7 and day 14
Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 7 followed by Baha 5 SP or Baha 6 Max at day 14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use > 16 hours | 1 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | No change battery in device | 14 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use 6-8 hours | 2 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Change to their own SP | 4 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Change battery in device | 2 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | No change to their own SP | 12 Participants |
| Baha 6 Max | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use 10-16 hours | 13 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | No change to their own SP | 13 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use 10-16 hours | 9 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use 6-8 hours | 6 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Daily use > 16 hours | 1 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Change battery in device | 8 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | No change battery in device | 8 Participants |
| Unaided | Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary | Change to their own SP | 3 Participants |
Secondary
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Participant rating Yes or No for internal noise after listening to sound clips.
Time frame: Day 14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Baha 6 Max | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 1-Yes | 1 Participants |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 1-No | 15 Participants |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 2-Yes | 0 Participants |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 2-No | 16 Participants |
| Unaided | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 2-No | 16 Participants |
| Unaided | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 1-Yes | 0 Participants |
| Unaided | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 2-Yes | 0 Participants |
| Unaided | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise | Sound clip 1-No | 16 Participants |
Secondary
Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
Participant rating for listening effort assessed with the Borg scale. The Borg scale measures the level of effort it takes trying to hear what is said in a sound clip. The scale is from 0-10 where 0= no effort at all and 10=maximal effort.
Time frame: Day 14
Population: Data are for sound clip 1. No data available for sound clip 2.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 6 Max | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | 1.97 Score on a scale | Standard Deviation 1.9 |
| Unaided | Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort. | 3.02 Score on a scale | Standard Deviation 2.6 |
Secondary
Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words
Time frame: Day 0, day 7 and day 14
Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | 88.4 Percentage of correct words | Standard Deviation 14.4 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet | 11 Percentage of correct words | Standard Deviation 21.8 |
Secondary
Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 9.0 and 10.0 kHz\]
Time frame: Day 0, day 7 and day 14
Population: Data for Baha 6 Max was collected on Day 0 and day 7 for all 16 participants. Data for unaided hearing was collected on day 14 for all 16 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 250 Hz | 29.7 db HL (decibel Hearing Level) | Standard Deviation 7.2 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 500 Hz | 20.9 db HL (decibel Hearing Level) | Standard Deviation 9.4 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 1000 Hz | 20.3 db HL (decibel Hearing Level) | Standard Deviation 8.8 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 2000 Hz | 23.4 db HL (decibel Hearing Level) | Standard Deviation 11.4 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 3000 Hz | 29.1 db HL (decibel Hearing Level) | Standard Deviation 15.4 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 4000 Hz | 35.0 db HL (decibel Hearing Level) | Standard Deviation 14.1 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 6000 Hz | 36.9 db HL (decibel Hearing Level) | Standard Deviation 15.2 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 8000 Hz | 35.3 db HL (decibel Hearing Level) | Standard Deviation 20 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 9000 Hz | 36.3 db HL (decibel Hearing Level) | Standard Deviation 21.2 |
| Baha 6 Max | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 10000 Hz | 50.6 db HL (decibel Hearing Level) | Standard Deviation 19.8 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 8000 Hz | 65.6 db HL (decibel Hearing Level) | Standard Deviation 17.3 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 250 Hz | 46.3 db HL (decibel Hearing Level) | Standard Deviation 13.6 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 4000 Hz | 64.1 db HL (decibel Hearing Level) | Standard Deviation 17.8 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 500 Hz | 49.7 db HL (decibel Hearing Level) | Standard Deviation 12 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 10000 Hz | 72.2 db HL (decibel Hearing Level) | Standard Deviation 10.3 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 1000 Hz | 54.4 db HL (decibel Hearing Level) | Standard Deviation 12.6 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 6000 Hz | 65.0 db HL (decibel Hearing Level) | Standard Deviation 18.4 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 2000 Hz | 50.6 db HL (decibel Hearing Level) | Standard Deviation 50.6 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 9000 Hz | 70.0 db HL (decibel Hearing Level) | Standard Deviation 15.5 |
| Unaided | Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry | 3000 Hz | 55.3 db HL (decibel Hearing Level) | Standard Deviation 16.4 |
Secondary
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
Using validated lists of phonetically balanced sentences. Noise is kept constant at 65 dB SPL and the speech is adapted stepwise to establish the speech-to-noise ratio providing a 50% level of understanding
Time frame: Day 0 and day 7
Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise | -3.7 dB SNR | Standard Deviation 2.75 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise | -2.8 dB SNR | Standard Deviation 2.44 |
Secondary
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Participant rating on a likert scale from 1-5 where 1 represents the most negative and 5 represents the most positive experience of loudness, sound quality, sound clarity, speech understanding, presence of artefacts after listening to sound clips.
Time frame: Day 14
Population: No data for speech understanding on sound clip 2 and for sound clarity on sound clip 1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Loudness- sound clip 1 | 3.0 Score on a scale | Standard Deviation 0.5 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Loudness- sound clip 2 | 2.8 Score on a scale | Standard Deviation 0.9 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Artefacts- sound clip 1 | 4.69 Score on a scale | Standard Deviation 0.8 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Artefacts- sound clip 2 | 4.69 Score on a scale | Standard Deviation 0.5 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Speech understanding- sound clip 1 | 4.38 Score on a scale | Standard Deviation 0.89 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound quality- sound clip 1 | 4.25 Score on a scale | Standard Deviation 0.9 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound quality- sound clip 2 | 4.31 Score on a scale | Standard Deviation 0.7 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound clarity-sound clip 2 | 4.31 Score on a scale | Standard Deviation 0.9 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound clarity-sound clip 2 | 3.19 Score on a scale | Standard Deviation 1 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Loudness- sound clip 1 | 2.6 Score on a scale | Standard Deviation 0.5 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Speech understanding- sound clip 1 | 3.63 Score on a scale | Standard Deviation 1.1 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Loudness- sound clip 2 | 2.6 Score on a scale | Standard Deviation 0.6 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound quality- sound clip 2 | 3.44 Score on a scale | Standard Deviation 1.2 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Artefacts- sound clip 1 | 4.63 Score on a scale | Standard Deviation 1.1 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Sound quality- sound clip 1 | 3.31 Score on a scale | Standard Deviation 1.2 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating | Artefacts- sound clip 2 | 4.5 Score on a scale | Standard Deviation 1 |
Secondary
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Time frame: Day 0 and day 7
Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | 88.4 Percentage of correct words | Standard Deviation 14.4 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet | 77.9 Percentage of correct words | Standard Deviation 25.1 |
Secondary
Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
Sound-field \[0.25, 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 9.0 and 10.0 kHz\]
Time frame: Day 0 and day 7
Population: 16 participants assessed Baha 6 Max or Baha 5 SP at day 0 followed by Baha 5 SP or Baha 6 Max at day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 250 Hz | 29.7 db HL (decibel Hearing Level) | Standard Deviation 7.2 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 500 Hz | 20.9 db HL (decibel Hearing Level) | Standard Deviation 9.4 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 1000 Hz | 20.3 db HL (decibel Hearing Level) | Standard Deviation 8.8 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 2000 Hz | 23.4 db HL (decibel Hearing Level) | Standard Deviation 11.4 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 3000 Hz | 29.1 db HL (decibel Hearing Level) | Standard Deviation 15.4 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 4000 Hz | 35 db HL (decibel Hearing Level) | Standard Deviation 14.1 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 6000 Hz | 36.9 db HL (decibel Hearing Level) | Standard Deviation 15.2 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 8000 Hz | 35.3 db HL (decibel Hearing Level) | Standard Deviation 120 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 9000 Hz | 36.3 db HL (decibel Hearing Level) | Standard Deviation 20 |
| Baha 6 Max | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 10000 Hz | 50.6 db HL (decibel Hearing Level) | Standard Deviation 19.8 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 8000 Hz | 56.9 db HL (decibel Hearing Level) | Standard Deviation 22 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 250 Hz | 34.1 db HL (decibel Hearing Level) | Standard Deviation 8.2 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 4000 Hz | 37.5 db HL (decibel Hearing Level) | Standard Deviation 16.2 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 500 Hz | 24.1 db HL (decibel Hearing Level) | Standard Deviation 10.8 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 10000 Hz | 65.3 db HL (decibel Hearing Level) | Standard Deviation 8.5 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 1000 Hz | 23.1 db HL (decibel Hearing Level) | Standard Deviation 10.5 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 6000 Hz | 39.7 db HL (decibel Hearing Level) | Standard Deviation 17.4 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 2000 Hz | 25.3 db HL (decibel Hearing Level) | Standard Deviation 12.7 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 9000 Hz | 65.3 db HL (decibel Hearing Level) | Standard Deviation 12.6 |
| Unaided | Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry | 3000 Hz | 33.4 db HL (decibel Hearing Level) | Standard Deviation 15.7 |