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Clinical Trials/NL-OMON41455
NL-OMON41455
Completed
Phase 4

Benefits of the HiResolutionTM Bionic Ear System in Adults with Low-Frequency Hearing. - AB-RCA-01-13

Advanced Bionics Corporation0 sites12 target enrollmentTBD
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Conditionsmild to severe deafness10019243

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
mild to severe deafness
Sponsor
Advanced Bionics Corporation
Enrollment
12
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • •18 years of age or older
  • •Definite Postlingual onset of severe\-to\-profound hearing loss as documented by completing main stream primary education
  • •Preferably, aided mono\- or bisyllabic word score of \>\= 15 % at 65 dB SPL in quiet in the ear to be implanted
  • •Local language proficiency
  • •Bilateral, sensorineural hearing loss of a mild to moderate degree in the low frequencies and a severe or a greater degree of hearing loss in the mid\-to\-high frequencies, defined as pure\-tone thresholds (PT):
  • •\- PT \<\= 60 dB HL at 250, 500, and 750 Hz BUT at one of these 3
  • •frequencies a value \<\= 70 dB is acceptable
  • •\- PT \>\= 70 dB HL at 2000, 4000, and 8000 Hz
  • •Contralateral ear PTA ± 30 dB HL at 250, 500, 750 and 1000 Hz as compared to the ear to be implanted

Exclusion Criteria

  • •Previous inner or major middle ear surgery or active middle ear pathology.
  • •Cochlear malformation or obstruction as confirmed by pre OP MRI (an MRI is required to exclude obstruction when history indicates a higher risk for obstructions)
  • •Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
  • •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study\-related procedures
  • •Evidence of central auditory lesion or compromised auditory nerve
  • •Concurrent participation in other study

Outcomes

Primary Outcomes

Not specified

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