A Phase 3 interventional study of AAVAnc80-hOTOF via Akouos Delivery Device and AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism in Sensorineural Hearing Loss, Bilateral, sponsored by Eli Lilly and Company. Recruiting at 9 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
Part A of this trial evaluated the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF (LY888891) and evaluated the Akouos Delivery Device, together with the Precision Delivery Mechanism (as applicable), to safely achieve the intended product performance.
Part B of the trial is an open-label, global expansion phase to confirm the efficacy and safety of one dose level of AAVAnc80-hOTOF administered in one or both ear(s). Part B will also evaluate the Intracochlear Delivery System (IDS), which consists of the Akouos Delivery Device, the Precision Delivery Mechanism, and an off-the-shelf syringe.
Part C is a region-specific expansion phase. Part C participants will receive the same dose level of AAVAnc80-hOTOF as participants in Part B, in one or both ear(s) utilizing the IDS.
Part D is a sequential administration phase that allows participants who received AAVAnc80-hOTOF previously in a single ear to receive AAVAnc80-hOTOF administration in the other ear utilizing the IDS.
The following two dose levels were tested in Part A:
The following dose level will be tested in Part B, C, and D:
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's planned enrollment of 48 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Criteria for Inclusion:
Criteria for Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort 1a: Two participants aged 7 to 17 years old (inclusive) to receive intracochlear administration of AAVAnc80-hOTOF (dose level 1) in the study ear using a sterile, one-time use investigational medical device Cohort 1b: Up to six eligible participants will be enrolled to receive intracochlear administration of AAVAnc80-hOTOF (dose level 1) in the study ear using a sterile, one-time use investigational medical device; the first three participants will be at least two years of age at the time of AAVAnc80-hOTOF administration and the next three participants may be of any age
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device
Cohort 2: Up to six eligible participants will be enrolled to receive intracochlear administration of AAVAnc80-hOTOF (dose level 2) in the study ear using a sterile, one-time use investigational medical device; the first three participants will be at least two years of age at the time of AAVAnc80-hOTOF administration and the next three participants may be of any age
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device
Bilateral Expansion: up to eight eligible participants of any age, and no cochlear implants, may be eligible for enrollment into the Bilateral Expansion Cohort (simultaneous bilateral administration of AAVAnc80-hOTOF).
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
Part B: Sixteen participants of any age will be enrolled to receive a single unilateral or bilateral administration of AAVAnc80-hOTOF. Participants with one CI will receive unilateral administration of AAVAnc80-hOTOF, while participants with no CIs will have the choice to receive a unilateral or bilateral administration of AAVAnc80-hOTOF, provided both ears meet eligibility criteria.
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
Up to ten eligible participants of any age will be enrolled in a region-specific expansion phase to receive a single unilateral or bilateral administration of AAVAnc80-hOTOF. Participants with one CI will receive unilateral administration of AAVAnc80-hOTOF, while participants with no CIs will have the choice to receive a unilateral or bilateral administration of AAVAnc80-hOTOF, provided both ears meet eligibility criteria.
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
Participants of any age may be enrolled into Part D, which is a sequential administration phase that allows participants who received unilateral administration of AAVAnc80-hOTOF in AK-OTOF-101 (Parts A, B, or C) the option to receive dose administration of AAVAnc80-hOTOF in the contralateral ear after completing the Year 1 visit.
Combination Product: AAVAnc80-hOTOF via Akouos Delivery Device and Precision Delivery Mechanism
AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time unilateral intracochlear administration using the Akouos Delivery Device.
AAVAnc80-hOTOF is a sterile suspension intended to be administered via a one-time bilateral intracochlear administration using the Akouos Delivery Device together with the Precision Delivery Mechanism.
Part A: Frequency of Adverse Events (AEs)
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery system)
Time frame: through trial completion, approximately 1 year
Co-Primary Parts B, C, and D: ABR Threshold
Changes from baseline in ABR intensity threshold (decibels normal hearing level \[dB nHL\]
Time frame: through trial completion, approximately 1 year
Co-Primary Parts B, C, and D: Pure-tone Average
Changes from baseline in the average of behavioral pure-tone audiometry thresholds
Time frame: through trial completion, approximately 1 year
Part A: Auditory Brainstem Response (ABR) Threshold
Changes from baseline in ABR intensity threshold (decibels normal hearing level \[dB nHL\])
Time frame: through trial completion, approximately 1 year
Part A: Performance of the Akouos Delivery Device and Precision Delivery Mechanism
Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-hOTOF to the intracochlear space
Time frame: through trial completion, approximately 1 year
Parts B, C, and D: Auditory Skills Checklist (ASC)
Change from Baseline for ASC total score
Time frame: through trial completion, approximately 1 year
Parts B, C, and D: Performance of the Intracochlear Delivery System to deliver AAVAnc80-hOTOF to the intracochlear space
Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-hOTOF to the intracochlear space
Time frame: through trial completion, approximately 1 year
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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