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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16
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.
Cochlear Bone Anchored Solutions AB (CBAS)
Mölnlycke, Sweden
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
Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
Time frame: Day 14
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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
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
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