Evidence map›Paper›PMID 39339272›Full record

ArticlePharmaceutics2024

Molded Round Window Niche Implant as a Dexamethasone Delivery System in a Cochlear Implant-Trauma Animal Model.

Chunjiang Wei, Ziwen Gao, Robert Mau, Thomas Eickner, Gabor Jüttner, Nicklas Fiedler, Hermann Seitz, Thomas Lenarz, Verena Scheper

Abstract read
In one paragraph

Article in Pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Chunjiang WeiDepartment of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.
Ziwen GaoDepartment of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.ORCID 0000-0002-9565-8838
Robert MauMicrofluidics, Faculty of Mechanical Engineering and Marine Technology, University of Rostock, Justus-von-Liebig Weg 6, 18059 Rostock, Germany.ORCID 0000-0003-3748-4275
Thomas EicknerInstitute for Biomedical Engineering, University Medical Center Rostock, University of Rostock, Friedrich-Barnewitz Straße 4, 18119 Rostock, Germany.
Gabor JüttnerKunststoff-Zentrum in Leipzig gGmbH, Erich-Zeigner-Allee 44, 04229 Leipzig, Germany.
Nicklas FiedlerInstitute for Biomedical Engineering, University Medical Center Rostock, University of Rostock, Friedrich-Barnewitz Straße 4, 18119 Rostock, Germany.ORCID 0000-0002-4436-7010
Hermann SeitzMicrofluidics, Faculty of Mechanical Engineering and Marine Technology, University of Rostock, Justus-von-Liebig Weg 6, 18059 Rostock, Germany.ORCID 0000-0003-3401-0090
Thomas LenarzDepartment of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.ORCID 0000-0002-9307-5989
Verena ScheperDepartment of Otolaryngology, Hannover Medical School, Carl-Neuberg-Str. 1, 30625 Hannover, Germany.ORCID 0000-0001-8618-8793

Funding

Federal Ministry of Education and Research of Germany 03ZZ0928L
6 · The paper itself

Abstract

backgroundPreserving residual hearing after cochlear implant (CI) surgery remains a crucial challenge. The application of dexamethasone (DEX) has been proven to positively affect residual hearing. To deliver DEX in a localized and controlled way, a round window niche implant (RNI), allowing drug diffusion via the round window membrane into the cochlea, may be used. To prove this concept, an RNI for guinea pigs as a CI-trauma model was manufactured by molding and tested for its drug release in vitro and biological effects in vivo.

methodsThe RNIs were molded using silicone containing 10% DEX. Release was analyzed over time using high-performance liquid chromatography (HPLC). Fourteen adult guinea pigs were randomly assigned to two groups (CI or CI + RNI group). All animals received a unilateral CI electrode insertion trauma followed by CI insertion. The CI + RNI group was additionally implanted with an RNI containing 10% DEX. Animals were followed up for 4 weeks. Acoustically evoked auditory brainstem response and impedance measurement, micro-computed tomography (µCT) imaging, and histology were performed for evaluation.

resultsDEX was released for more than 250 days in vitro, with an initial burst followed by a slower release over time. Comparing the hearing threshold shift (from day 0 to day 28) of the CI and CI + RNI groups, significant differences were observed at 32 and 40 kHz. The impedance shift at basal contacts was lower in the CI + RNI group than in the CI group. Moreover, the fibrosis in the lower basal turn was reduced in the CI + RNI group in contrast to the CI group.

conclusionsThe RNI containing 10% DEX has anti-inflammatory potential concerning fibrosis inhibition and has beneficial effects on hearing preservation at high frequencies.

Indexed as

cochlear implant surgerydexamethasoneguinea piglocal inner ear drug therapylocal pharmacotherapyround window niche implant

Identifiers

PMID39339272
PMCPMC11434969

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.