Home Test of New Sound Processor

• Sponsor: Cochlear (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04559282
• Collaborator: Statistiska Konsultgruppen (Other)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Device: New Sound Processor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Pivotal, Prospective, Single-centre, Randomized Test Order, Crossover, Open Label Study Comparing the Performance of a New Sound Processor With Unaided Hearing and Baha 5 in Adult Subjects With Conductive or Mixed Hearing Loss
• Actual Study Start Date: Sep 23, 2020
• Actual Primary Completion Date: Nov 27, 2020
• Actual Study Completion Date: Nov 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: New SP followed by Baha 5 SP followed by single blinded SP Aided hearing with new Sound Processor followed by aided hearing with the Baha 5 sound processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).	Device: New 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.
Experimental: Baha 5 SP followed by the New SP followed by single blinded SP Aided hearing with Baha 5 sound processor followed by aided hearing with the new Sound Processor followed by unaided hearing followed by aided hearing with the new Sound Processor and Baha 5 in a laboratory environment (subject blinded for hearing testing).	Device: New 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF [Day 14]

Secondary Outcome Measures

1. 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.

2. 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

3. 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]

4. 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.

5. 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.

6. 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.

7. 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.

8. 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]

9. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cochlear Bone Anchored Solutions AB (CBAS)	Mölnlycke		Sweden	SE-435 33

Sponsors and Collaborators

• Cochlear
• Statistiska Konsultgruppen

Investigators

• Study Director: Karin Ganlöv, MD, Cochlear

Study Documents (Full-Text)

• Study Protocol - Oct 29, 2020
• Statistical Analysis Plan - Mar 3, 2021

More Information

Publications

None provided.

• Responsible Party: Cochlear
• ClinicalTrials.gov Identifier: NCT04559282
• Other Study ID Numbers: CBAS5779
• First Posted: Sep 22, 2020
• Last Update Posted: Nov 22, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cochlear: Conductive Hearing Loss; Mixed Hearing Loss
• Additional relevant MeSH terms: Hearing Loss; Deafness

Study Results

Participant Flow

Recruitment Details	16 participants were recruited in one centre from 23 September 2020 to 27 November 2020.

Arm/Group Title	Baha 6 Max Followed by Baha 5 SP Followed by Unaided Hearing	Baha 5 SP Followed by Baha 6 Max Followed by Unaided Hearing
Arm/Group Description	Participants received Baha 6 Max followed by Baha 5 SP followed by Unaided	Participants received Baha 5 SP followed by Baha 6 Max followed by Unaided
Period Title: Intervention 1 (Day 0)
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0
Period Title: Intervention 1 (Day 0)
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0
Period Title: Intervention 1 (Day 0)
STARTED	8	8
COMPLETED	8	8
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Crossover, participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 75%
>=65 years	4 25%
Sex: Female, Male (Count of Participants)
Female	11 68.8%
Male	5 31.3%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
Sweden	16 100%

Outcome Measures

1. Primary Outcome

Title	Hearing Performance of Speech in Noise for Unaided Hearing and the Baha 6 Max Assessed Via Adaptive Speech Test in Noise
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Unaided
Arm/Group Description	Baha 6 Max SP	Unaided hearing
Measure Participants	16	16
Mean (Standard Deviation) [db SNR (decibel Speech in Noise Ratio)]	-3.7 (2.75)	4.8 (6.55)

2. Primary Outcome

Title	Participant Preference for the Baha 6 Max or Baha 5 SP Assessed Via Questions in the eCRF
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Count of Participants [Participants]	13 81.3%	3 NaN

3. Secondary Outcome

Title	Descriptive Hearing Performance for the Baha 6 Max and Baha 5 SP in a Home/Normal Hearing Environment Assessed Via a Diary
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Daily use 10-16 hours	13 81.3%	9 NaN
Daily use 6-8 hours	2 12.5%	6 NaN
Daily use > 16 hours	1 6.3%	1 NaN
Change battery in device	2 12.5%	8 NaN
No change battery in device	14 87.5%	8 NaN
Change to their own SP	4 25%	3 NaN
No change to their own SP	12 75%	13 NaN

4. Secondary Outcome

Title	Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Adaptive Speech Test in Noise
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Mean (Standard Deviation) [dB SNR]	-3.7 (2.75)	-2.8 (2.44)

5. Secondary Outcome

Title	Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Thresholds Audiometry
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha SP
Measure Participants	16	16
250 Hz	29.7 (7.2)	34.1 (8.2)
500 Hz	20.9 (9.4)	24.1 (10.8)
1000 Hz	20.3 (8.8)	23.1 (10.5)
2000 Hz	23.4 (11.4)	25.3 (12.7)
3000 Hz	29.1 (15.4)	33.4 (15.7)
4000 Hz	35 (14.1)	37.5 (16.2)
6000 Hz	36.9 (15.2)	39.7 (17.4)
8000 Hz	35.3 (120.0)	56.9 (22.0)
9000 Hz	36.3 (20.0)	65.3 (12.6)
10000 Hz	50.6 (19.8)	65.3 (8.5)

6. Secondary Outcome

Title	Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Speech Test in Quiet
Description	Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words.
Time Frame	Day 0 and day 7

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Mean (Standard Deviation) [Percentage of correct words]	88.4 (14.4)	77.9 (25.1)

7. Secondary Outcome

Title	Hearing Performance for the Baha 6 Max and Baha 5 SP Assessed Via Participant Rating
Description	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

Outcome Measure Data

Analysis Population Description

No data for speech understanding on sound clip 2 and for sound clarity on sound clip 1.

Arm/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Loudness- sound clip 1	3.0 (0.5)	2.6 (0.5)
Loudness- sound clip 2	2.8 (0.9)	2.6 (0.6)
Artefacts- sound clip 1	4.69 (0.8)	4.63 (1.1)
Artefacts- sound clip 2	4.69 (0.5)	4.5 (1.0)
Speech understanding- sound clip 1	4.38 (0.89)	3.63 (1.1)
Sound quality- sound clip 1	4.25 (0.9)	3.31 (1.2)
Sound quality- sound clip 2	4.31 (0.7)	3.44 (1.2)
Sound clarity-sound clip 2	4.31 (0.9)	3.19 (1.0)

8. Secondary Outcome

Title	Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Internal Noise
Description	Participant rating Yes or No for internal noise after listening to sound clips.
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Sound clip 1-Yes	1 6.3%	0 NaN
Sound clip 1-No	15 93.8%	16 NaN
Sound clip 2-Yes	0 0%	0 NaN
Sound clip 2-No	16 100%	16 NaN

9. Secondary Outcome

Title	Hearing Performance for Baha 6 Max and Baha 5 SP Assessed Via Participant Rating for Listening Effort.
Description	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

Outcome Measure Data

Analysis Population Description

Data are for sound clip 1. No data available for sound clip 2.

Arm/Group Title	Baha 6 Max	Baha 5
Arm/Group Description	Baha 6 Max SP	Baha 5 SP
Measure Participants	16	16
Mean (Standard Deviation) [Score on a scale]	1.97 (1.9)	3.02 (2.6)

10. Secondary Outcome

Title	Hearing Performance for Baha 6 Max and Unaided Assessed Via Thresholds Audiometry
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Unaided
Arm/Group Description	Baha 6 Max SP	Unaided hearing
Measure Participants	16	16
250 Hz	29.7 (7.2)	46.3 (13.6)
500 Hz	20.9 (9.4)	49.7 (12.0)
1000 Hz	20.3 (8.8)	54.4 (12.6)
2000 Hz	23.4 (11.4)	50.6 (50.6)
3000 Hz	29.1 (15.4)	55.3 (16.4)
4000 Hz	35.0 (14.1)	64.1 (17.8)
6000 Hz	36.9 (15.2)	65.0 (18.4)
8000 Hz	35.3 (20.0)	65.6 (17.3)
9000 Hz	36.3 (21.2)	70.0 (15.5)
10000 Hz	50.6 (19.8)	72.2 (10.3)

11. Secondary Outcome

Title	Hearing Performance for Baha 6 Max and Unaided Assessed Via Speech Test in Quiet
Description	Using monosyllabic words presented at 65 dB SPL with scores recorded as % correct words
Time Frame	Day 0, day 7 and day 14

Outcome Measure Data

Analysis Population Description

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/Group Title	Baha 6 Max	Unaided
Arm/Group Description	Baha 6 Max SP	Unaided hearing
Measure Participants	16	16
Mean (Standard Deviation) [Percentage of correct words]	88.4 (14.4)	11 (21.8)

Adverse Events

Time Frame	14 days
Adverse Event Reporting Description	Participants received Baha 6 Max or Baha 5 SP followed by Baha 5 SP or Baha 6 Max followed by Unaided
Arm/Group Title	Baha 6 Max		Baha 5		Unaided
Arm/Group Description	Baha 6 Max SP		Baha 5 SP		Unaided hearing
All Cause Mortality
	Baha 6 Max		Baha 5		Unaided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)
Serious Adverse Events
	Baha 6 Max		Baha 5		Unaided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Baha 6 Max		Baha 5		Unaided
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.